case report forms (crfs) - critical care nutrition · example: t-bilirubin was ... study day 1 =...

Version: Sept 10, 2010 1

A Randomized Trial of Enteral Glutamine to Minimize Thermal Injury

Human Research Protection Office (HRPO) Log Number A-15774

HRPO Proposal Number 09155001 Clinical trials.gov ID #NCT00985205

CASE REPORT FORMS (CRFs)

Site Number Enrollment Number

-

________________________________________________________ Name of Research Coordinator(s) completing this CRF (Please print) _____________________________ Signature __________________________________ Date completed and signed (dd/mmm/yyyy)

Please direct questions to: Rupinder Dhaliwal Project Leader Tel: 613-549-6666 ext. 3830 Fax: 613-548-2428 Email: [email protected]

mailto:[email protected]�


Table of Contents

CRF Page/Description Page #

General Instructions 3

Screening Inclusion 5

Screening Exclusion 7

Pre-randomization/Randomization 9

Severity of Burn Assessment 11

Baseline 13

Nutrition Assessment/Timing 15

Daily Monitoring 17

Daily Organ Dysfunction 19

Daily Laboratory 21

Daily Nutrition 23

Study blood work 25

Burn Related Operative Procedures 27

Blood Products 29

Concomitant Medications 31

Antibiotics, Antifungals & Antivirals 33

Microbiology 35

Infection Adjudication 37

Hospitalization Overview 39

Follow-Up 41

Comments 43

Investigator Confirmation 45

Protocol Violation 47


General Instructions 1. CRFs must be numbered using both the site number and the patient randomization number assigned by the web-based Central Randomization System (CRS). Enter these numbers on the top right hand corner of every page. 2. Use only black ball-point ink when completing this form.

3. All data requested in this CRF is to be taken from the patient’s hospital chart (or original source document).

4. Unless otherwise instructed, there can be no blanks. If no data is available use one of the standard annotations below to document the reason:

ND- not done Data is unavailable (or not applicable) because the measure wasn’t taken or test was not done. Example: T-Bilirubin was not done on a particular study day. N/K—not known

Every effort has been made to find the data but it is missing from source documents. Example: A particular data point was NOT entered in the medical chart. Or ICU flow sheet is missing.

5. Corrections should be made by crossing out the incorrect entry with a single line, then entering the correct data beside the original entry, followed by initialing and dating the new entry. Do not use correction fluid.

6. Date format will be day-month-year, entered as dd/mmm/yyyy. For example: 08 Mar 2010.

7. All times should be recorded using the 24 hour (military) clock. Midnight is to be entered as 00:00 hrs.

8. Anywhere in the CRF that “Other, specify” is indicated and/or has been checked, there must be an entry on the line provided further describing what “other” means.

9. For pages that may require more than one completed page (e.g. Microbiology page) indicate the page number in

space provided at the top right side of the page. The page numbering for these pages begins with 1. When the page is the last of the series, check the box in the space.

10. Study days MUST be defined as follows:

Study Day 1 = ICU admit date (not randomization) and time until 23:59 that day Study Day 2 = the subsequent day starting at 00:00 to 23:59and so on for other days. Example 1: A patient is admitted to unit on March 8 2010 @ 02:00. The study days would be: Study Day 1= 8/Mar/2010 @ 02:00 to 8/Mar/2010 @ 23:59 Study Day 2 = 9/Mar/2010 @ 00:00 to 9/Mar/2010 @ 23:59 and so on Example 2: A patient is admitted to the unit on March 8 2010 @ 14:00. The study days would be: Study Day 1= 8/Mar/2010 @ 14:00 to 8/Mar/2010 @ 23:59 Study Day 2 = 9/Mar/2010 @ 00:00 to 9/Mar/2010 @ 23:59 and so on

11. The duration of data collection and frequency will vary depending upon each Case Report Form and is outlined as follows:

To be collected once: Initial Burn Assessment, Baseline, Nutrition Assessment/Timing, Hospitalization Overview & Follow-Up: at 6 months from time of admission to ICU

To be collected from Study Day 1 (ICU admission) until 10 days post last successful grafting:

Daily: Organ Dysfunction & Labs (while ventilated), Daily Nutrition, Daily Monitoring, Burn related Operative Proce-dures, Blood Products, Concomitant Medications, Antibiotics/Antifungals/Antivirals & Microbiology.

Weekly/other specified intervals: Assessment/Timing (weekly prescriptions), Organ dysfunction, Study Blood Work & Infection Adjudication

To be collected from randomization until 7 days post last successful grafting:

Daily: Daily monitoring (dose of study intervention received) Refer to specific instructions for each case report form. NOTE: Pages 11-45 inclusive refer to the CRFs that need to be completed and sent to the Methods centre. Ensure that you have photocopied one blank set per randomized patient (copy only odd numbered pages from 11-45).


Screening - Inclusion Instructions

Date and time of screening

Enter the date and time you screen the patient.

Inclusion Criteria 1. Total Burn Surface Area (TBSA)

Only patients who meet inclusion criteria should be entered into the Central Randomization System (CRS). Each patient must meet all three of the criteria to be included. Eligibility must be confirmed by the Site Investigator/delegate. The TBSA must be at least 20%. Check yes if the TBSA is ≥ 20. Record the total burn surface area expressed as a percentage (this assessment is to be made by the attending surgeon/physician based on his/her clinical judgment). This information must be obtained from the attending surgeon/delegate before randomization can occur.

2. Presence of either 2nd or 3rd degree burns requiring grafting

The presence of deep 2nd degree or deep 3rd degree burns requiring grafting is an assessment that must be made by the attending surgeon/physician). This information must be obtained from the attending surgeon/delegate before randomization can occur. Check the box indicating that this criteria is met.

3. Age + TBSA% The current age of the patient plus the % TBSA must be in the range of 60-119. Record the age, the % TBSA and the total score. Check the box indicating that this criteria is met.

Randomization must occur within 48 hours of admission to the ICU (burn unit). Refer to exclusion criteria for more details.

The following pages from page 4- 9 inclusive, are worksheets only. When you are ready to screen and/or randomize a patient, transfer the data from these worksheets into the Central Randomization System (CRS) at

https://ceru.hpcvl.queensu.ca/randomize/

The following pages from page 4- 9 inclusive, are worksheets only. When you are ready to screen and/or randomize a patient, transfer the data from these worksheets into the Central Randomization System (CRS) at

https://ceru.hpcvl.queensu.ca/randomize/

Refer to Implementation Manual for further instructions regarding the CRS


Screening—Inclusion

D D M M M Y Y Y Y :

(24 hour clock)

H H M M Date and time of Screening

Inclusion Criteria

1. Total Burn Surface Area (TBSA) ≥20%


-

TBSA

Yes

3. Age + TBSA = (range 60-119) Yes

+ =

%

2. Presence of Deep 2nd and/or Deep 3rd degree burns requiring grafting Yes


Exclusion criteria Record all exclusion criteria that the patient meets.

If any one of the eleven criteria below are met, then the patient is NOT ELIGIBLE. 1. >48 hours from admission to ICU to time of consent 2. Patients < 18 years OR > 80 years of age 3. Liver cirrhosis—Child’s Class C liver disease (see chart below)

4. Pregnancy Urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice. 5. Associated multiple fractures or severe head trauma Multiple fractures are defined as ≥ 2 long bone fractures or ≥ 1 long bone fracture plus a pelvic fracture. Long bones refer to femur, tibia, fibula, humerus, radius, ulna. Severe head trauma is defined as an injury that, in the opinion of the investigator, is a severe disabling or life threatening traumatic brain injury 6. Absolute contra-indication for Enteral Nutrition Intestinal occlusion or perforation, abdominal injury. Being NPO is not considered a contraindication for Enteral Nutrition. 7. Patients admitted > 48 hours post burn Patients admitted more than 48hrs post burn (for patients that receive standardized burn care and resuscitation

prior to admission to ICU, this exclusion criteria may be extended to more than 96 hrs post burn; if this is the case consent must be obtained within 24 hours of admission to burn ICU, according to the judgement of the Site Investigator)

8. Patient with injuries from high voltage electrical shock 9. Patient who is moribund. This may be defined as not expected to be in the ICU for more than 48 hours due to imminent death. 10. Patients with extreme body size: BMI <18 or >50 kg/m2 11. Enrollment in another industry sponsored ICU intervention study Co-enrollment in academic studies will be considered on a case by case basis. If the patient does NOT meet any of the above exclusion criteria, patient is eligible for randomization and you may proceed to the Pre-randomization/Randomization form. To minimize any potential contamination, patients that have received glutamine for > 24 hrs

before randomization should NOT be included

Screening – Exclusion Instructions

Criteria Points assigned 1 2 3

Total Bilirubin SI units

< 2mg/dL or < 34 μmol/L

2 - 3 mg/dL or 34 – 51 μmol/L

> 3 mg/dL or > 51 μmol/L

Serum Albumin SI units

> 3.5 g/dL or > 35 g/L

2.8—3.5 g/dL 28 – 35 g/L

< 2.8 g/dL or < 28 g/L

Prothrombin time or INR

< 4 seconds < 1.7

4 – 6 seconds 1.7 – 2.3

> 6 seconds > 2.3

Ascites* Absent Slight Moderate

Encephalopathy None Moderate Severe

* Refer to ultrasound results. If ascites has been drained in the past, it should be considered Moderate.

The Child’s Class C score is obtained by adding the points for all 5 criteria in this table. Any patient having a score of 10 – 15 falls into Group C (severe hepatic impairment), which would be considered exclusion for this study.


Screening—Exclusion

Exclusion Criteria

1. >48 hours from admission to ICU to time of consent Yes No

3. Liver cirrhosis– Child’s Class C liver disease Yes No

4. Pregnancy Yes No

5. Associated multiple fractures or severe head trauma Yes No

6. Absolute contra-indication for EN Yes No

7. Patients admitted to ICU > 48 hrs post burn (if field treated > 96 hrs) Yes No

8. Patients with injuries from high voltage electrical shock Yes No

9. Patient who is moribund Yes No

10. Patients BMI < 18 or > 50 kg/m2 Yes No

2. Patients < 18 years OR > 80 years of age Yes No

11. Enrollment in another industry sponsored ICU intervention study (co-enrollment in academic studies will be considered on a case by case basis)

Yes No


-


Pre Randomization / Randomization Instructions

General Instructions If all inclusion criteria are present AND no exclusion criteria are met the patient is considered eligible for randomization into the study. Check all appropriate boxes on this form.

Patient co-enrolled in another academic ICU study

Is the patient co-enrolled in another academic ICU study, Yes or No? If Yes, then enter the name(s) of the study(ies).

Consent Did you obtain consent? Yes or No. If YES, enter date and time of consent. If NO, choose the most important reason why the patient wasn’t randomized:

Randomization Date and Time

Log onto the Central Randomization System (CRS) to obtain the date and time of randomization. Instructions for CRS will follow.

Pharmacy Notification Record the date and time that pharmacy was notified.

Patient Eligibility Confirmed by MD

Enter the name of the physician who confirmed patient eligibility. This individual should be listed on the Site Delegation of Authority Log.

Pre Burn Weight Use patient’s pre-burn weight to avoid fluctuations due to large fluid shifts. Indicate by placing a √ whether the weight is:

measured (obtained by a weighing scale) estimated (obtained verbally from a healthcare professional or family)

Record weight (to the nearest decimal point).

Reason Description

No next of kin or substitute decision maker

The SDM or legally acceptable representative was not available for consent discussion within the required time frame.

Refused Consent The SDM or LAR refused participation. It is important to document the reason for the refusal to consent.

Missed the patient The patient was not identified by the site coordinator in time to approach for consent. Example: the patient was admitted over a long weekend.

Language Barriers

The SDM was not approached because of language barriers. A certified translator was not present.

Not approached for consent – Family dy-namics

The SDM was not approached due to emotional stress or complicated family dynamics.

Pharmacy not available

The pharmacy not available to prepare the investigational product.

Workload Issues There was inadequate Research staff present to follow the patient

Other Specify the reason(s) for not obtaining consent that is not listed above. Example: patient received glutamine for >24 hrs before randomization


Pre Randomization

Yes No Did you obtain consent?

If Yes Date and time of Consent D D M M M Y Y Y Y :

(24 hour clock)

H H M M

Randomization

D D M M M Y Y Y Y :

(24 hour clock)

H H M M Date and time of randomization

D D M M M Y Y Y Y :

(24 hour clock)

H H M M Date and time pharmacy notified

If No, choose the most important reason the patient wasn’t randomized

No next of kin or substitute decision maker

Refused consent

Missed patient Other, please specify:_________________ _______________________________________ Language barriers

Not approached for consent—family dynamics

Pharmacy not available

Patient Eligibility Confirmed by: Name of Physician: ___________________________

Workload issues


-

Is this patient co-enrolled in another academic ICU study? Yes No If Yes, specify ___________________________

Pre-burn weight

measured

estimate kg .


Severity of Burn Injury Assessment Instructions

General Instructions

An initial assessment of the burn injury must be made by the attending surgeon/delegate within 72 hrs of injury. This is to be repeated once at hospital discharge or at the end of the study duration i.e. 10 days post last successful grafting, whatever occurs first.

Initial Assessment

Within 72 hours of the burn injury, have the attending surgeon/delegate provide an initial assessment of the following using the Lund-Browder chart (see Appendix 1):

superficial partial thickness burn (defined as expected to heal within 21 days without skin grafting) as %TBSA

deep partial/full thickness burn (defined as expected to require skin grafting) as % TBSA

Date of final assessment at discharge

Record the date of the final assessment done by the attending surgeon/delegate. This must be done at hospital discharge or 10 days post last successful grafting, whatever occurs first.

Final Assessment

Have the attending surgeon/delegate assess the % of area of the initial burned surface that required grafting as %TBSA

Date of initial assessment

Record the date of the initial assessment done by the attending surgeon/delegate. This must be done within 72 hours of the burn injury.


Severity of Burn Assessment

Superficial Partial thickness burn (expected to heal)

Deep partial/full thickness burn (expected to require grafting) %TBSA

%TBSA

INITIAL ASSESSMENT—to be done within 72 hours of burn injury

Date of initial assessment D D M M M 2 0 Y Y

Area of initial burned surface that required grafting %TBSA

FINAL ASSESSMENT—to be done 10 days post last successful grafting or at hospital discharge

Date of final assessment D D M M M 2 0 Y Y


-


Sex Place a √ in the appropriate box (male or female). Tick only one box.

Ethnic Group Choose the appropriate patient ethnicity from the following list: White Black or African American Hispanic Asian or Pacific Islander Native Other (please specify) ____________

APACHE II Go to the following website http://www.sfar.org/scores2/apache22.html#haut to calculate the APACHE II score. Record the calculated score. Reminder to use variables within the first 24 hrs of this ICU admission. If variables are not available from the first 24 hrs, go outside the 24 hr window and use data closest to ICU admission. NOTE: ensure that the units that you are using for serum sodium, potassium and white blood count are correct.

Comorbidities Enter all comorbidities present using the taxonomy provided (Appendix 2). Only those comorbidities found on the taxonomy listing should be recorded. If no comorbidities are present, record this as “00”.

Tobacco use Indicate whether the patient is a current smoker or uses tobacco, Yes or No.

Alcohol use Indicate whether the patient has a history of alcohol abuse, Yes or No.

Height Place a √ if height is measured (by yourself or other staff); estimated (obtained verbally from a healthcare professional or family); or unknown as it is not available in the patient chart or can’t be estimated. Before selecting this option please discuss with family to see if they are aware. Record height (to the first decimal point). Place a √ in the appropriate measurement scale (inches or meters).

BMI in kg/m2

A Body Mass Index must be calculated to determine eligibility. Body Mass Index is calculated as:

Weight in kg/height in metres2 (metric system)

Date and time of burn

Enter the date and time the burn injury trauma occurred. If the time of the burn is not available check no time available box.

Type of burn Select the type of burn that best describes the nature of the burn injury from this list (select only one): scald fire chemical radiation unknown other (please specify) ______________

Inhalation injury present?

Indicate if smoke inhalation injury is present (defined as restricted to injury below the glottis caused by products of combustion. Diagnosis of inhalation injury requires both of the following: 1) history of exposure to products of combustion 2) bronchoscopy revealing one of the following below the glottis

evidence of carbonaceous material signs of edema or ulceration

Hospital admit

Enter the date and time of hospitalization. This is the time of initial presentation to the emergency department or hospital ward, whichever is the earliest. If the patient is admitted directly to the ICU, this date and time becomes the Hospital admit date and time. If there is no time available, check the “no time available” box.

ICU admit Enter the actual admission date and time to ICU. If there is no time available, check the “no time available” box.

Invasive Mechanical ventilation Start

Enter the actual start date and time of invasive mechanical ventilation, even if this occurs at an external institution or in the field before admission to your unit. This may not be the same time that the patient was intubated, but should be the time invasive mechanical ventilation was started. If there is no time available, check the “no time available” box. If the patient never received invasive mechanical ventilation this ICU admission place a √ in the box.

Baseline Instructions


Baseline

Type of burn chemical fire radiation unknown

Other specify ____________________

scald

Inhalation injury present Yes No

D D M M M Y Y Y Y :

(24 hour clock)

H H M M Date and time of burn No time available

Comorbidities

Tobacco use Yes No

History of Alcohol abuse Yes No

Sex Male Female

Height measured

estimate

unknown

inches

meters .

BMI . kgs/m2

(24 hour clock)

No time available D D M M M 2 0 Y Y ICU Admit Date and Time H H M M

(24 hour clock)

No time available D D M M M 2 0 Y Y Hospital Admit Date and Time H H M M

(24 hour clock)

No time available D D M M M 2 0 Y Y Invasive Mechanical Ventilation Start Date and Time

H H M M

Ethnic Group

Other (specify)

White Black or African American Hispanic Asian or Pacific Islander Native

APACHE II


-

Patient never received invasive mechanical ventilation


Prescribed Energy and Protein needs

Contact your dietitian to obtain this information. These will need to be calculated by the dietitian at baseline (ICU admission or at the first dietitian assessment) and thereafter. Prescribed energy needs are to be calculated by using one (or a combination) of these methods: 1) Measured Energy Expenditure (MEE) by Indirect Calorimetry (preferred option), if available

MEE X 1.0 – 1.3 2) Basal Energy Expenditure (BEE) using Harris-Benedict Equation as follows:

BEE Women: 655 + ( 9.6 x weight in kg ) + ( 1.8 x height in cm ) - ( 4.7 x age in years ) BEE Men: 66 + ( 13.7 x weight in kg ) + ( 5 x height in cm ) - ( 6.8 x age in years ) If ≥ 50% Burn Surface Area, use BEE x 1.7- 2.0 If < 50% Burn Surface Area, use BEE x 1.5-1.6

3) Predictive equations such as Carlson et al 1992 or Milner et al 1994. Refer to the Standardization of Nutrition Practices document (Implementation Manual) for more details Use pre-burn weight. For Obese patients, if your standard practice is to adjust weight for obesity, use the weight you would use. If not, use ideal body weight. Please ask you dietitian for more details. Prescribed Protein needs are to be calculated by using the following: If > 50% burns, use 2g/kg/day to 3g/kg/day If < 50% burns, use 1.5 g/kg/day to 2 gm/kg/day Use pre-burn weight. For Obese patients, if your standard practice is to adjust weight for obesity, use the

weight you would use. If not, use ideal body weight. Please ask you dietitian for more details. If the prescribed energy or prescribed protein intake changes from week to week, record this in the appropriate row (Assessment #2, #3, etc) and record the date the prescription changed. In the event that the prescription changes more than once a week, record the average prescribed calories and protein over the week. If there are no changes in the prescription from baseline, place a check in the “No change from baseline” box.

Enteral Nutrition If the patient did not receive enteral nutrition during this ICU admission, place a √ in the box titled “Never received during this ICU admission”. If the patient received Enteral nutrition, record the following:

the actual start date and time of enteral nutrition. the actual stop date and time of enteral nutrition. This refers to the date enteral nutrition was

permanently discontinued, not stopped for temporary interruptions. This stop date may extend beyond past ICU discharge. If enteral nutrition is continued beyond hospital discharge, record hospital discharge date and time as the date and time that enteral nutrition was stopped.

Parenteral Nutrition If the patient did not receive parenteral nutrition during this ICU admission, place a √ in the box. If the patient received parenteral nutrition, record the following:

the actual start date and time of parenteral nutrition. the actual stop date and time of parenteral nutrition. This refers to the date parenteral

nutrition was permanently discontinued, not stopped for temporary interruptions. This stop date may extend beyond past ICU discharge. If parenteral nutrition is continued beyond hos-pital discharge, record hospital discharge date and time as the date and time that parenteral nutrition was stopped.

General Instructions These data are collected to determine how well the patient is being fed i.e the nutritional adequacy (% calories and protein received/prescribed) and the timing of initiation of nutrition.

Nutrition Assessment/Timing Instructions


Nutrition Assessment/Timing

Enteral Nutrition Never received during this ICU admission

Date and time enteral nutrition started D D M M M 2 0 Y Y :

(24 hour clock)

H H M M

Date and time enteral nutrition stopped

Parenteral Nutrition Never received during this ICU admission

Date and time parenteral nutrition started

Date and time parenteral nutrition stopped

Prescribed protein needs

grams Prescribed energy needs

kcal

Baseline Assessment

Date baseline prescription made D D M M M 2 0 Y Y

Prescribed protein needs grams Prescribed energy needs kcal Assessment # 2

Date 2nd prescription made No change from baseline


Date 3rd prescription made No change from Assessment #2

Prescribed protein needs

grams Prescribed energy needs

kcal Assessment #4


Date 5th prescription made No change from Assessment #4


Date 6th prescription made No change from Assessment #5

Date 4th prescription made No change from Assessment # 3


-

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y :

(24 hour clock)

H H M M

D D M M M 2 0 Y Y :

(24 hour clock)

H H M M

D D M M M 2 0 Y Y :

(24 hour clock)

H H M M


Daily Monitoring

General Information Duration of Data Collection

These data are collected to determine the compliance to the prescribed dose of the study intervention and to identify any Serious Adverse Events or Protocol Violations/Incidents that require expedited reporting to the Methods Centre. Study intervention is to be started within 48 hours of ICU admission. Given the material affect on the study, these data are to be collected as close to REAL TIME as possible and as follows:

Study Intervention: from randomization to 7 days post last successful grafting operation regardless of whether the patient is receiving enteral/parenteral nutrition, ventilation status or location of patient.

SAEs, Protocol Violations, etc: from randomization to 10 days post last successful grafting operation

Study Intervention Start Date and time

Enter the actual date and time study supplements were first started in the format dd/mmm/yyyy. If the intervention starts after 2 hrs from randomization, you must provide an explanation in the comments section of the Case Report Forms (page 43)

Study Intervention Stop Date and time

Enter the actual date and time study supplements were finally stopped in the format dd/mmm/yyyy. The stop date should be at the end of the study period i.e. 7 days after the last successful grafting operation or at discharge from ICU/hospital, whatever happens first.

Study Day # Record the Study Day number consecutively at the top of each column, starting at day 1. Reminder: Study Day 1 is the time from ICU admission until 23:59 that day, Study day 2 is the next 24 hrs period and so on.

Date Enter the dates corresponding to the calendar day for the corresponding study day number.

Time bolus given Record each time the Study medication was administered as a bolus. This is to be given at q 4 hr intervals if given via NG/feeding tube (unless weight is < 54 kgm) or TID if given po. Refer to the Implementation Manual for more details on the Investigational Product Administration.

# packets given Record the # packets given by the RN at each interval as documented in the medical chart.

Route Select the route by which the bolus was given at each interval, EN or PO.

Protocol Violation A protocol violation with the delivery of the study intervention occurs when the patient received < 80% of the total prescribed daily dosage (expressed as # packets). Refer to the Dosing Weight Chart and the Protocol Violation Form for more details (Implementation Manual). In the event that the patient does not receive at least 80% prescribed # packets, a Protocol Violation Form must be completed and faxed to CERU 613-548-2428 within 24 hours.

SAE Record yes or no if an unexpected serious adverse event (SAE) occurred. In the event that a SAE (serious and unexpected) has occurred, a SAE form must be completed and faxed to CERU 613-548-2428 within 24 hours. Refer to the SAE section in the Start Up Meeting binder for more details.

Indicate the page number in space provided at the top right side of the page. The page numbering for these pages begins with 1. When the page is the last of the series, check the box.

Page #:_____ √ box if last page of series


Site Number Enrollment #

-

Page #:_____ √ box if last page of Daily Monitoring

Study Day # dd/mmm/yyyy

Day # ___ Day # ___ Day # ___ Day # ___ Day # ___ Day # ___ Day # ___

Time (hh mm) # packets given Route






Protocol Violation

SAE

Yes No Yes No Yes No Yes No Yes No Yes No Yes No

Yes No Yes No Yes No Yes No Yes No Yes No Yes No

PO EN PO EN PO EN PO EN PO EN PO EN PO EN

Date and time study intervention actually started

D D M M M 2 0 Y Y : H H M M

Daily Monitoring

Date and time study intervention actually stopped

D D M M M 2 0 Y Y : H H M M







Daily Organ Dysfunction Instructions

General Instructions & Duration of Data Collection

These data are collected for calculation of SOFA and organ dysfunction scores. These data are to be collected as follows while patient is mechanically ventilated: Daily from study Day 1- 14 (first two weeks from ICU admission) Weekly from study Day 15 onwards until 10 days post last successful grafting



Heart rate Record the highest heart rate observed during the study day.

Core Temperature

Select either °C or °F for how the temperature was recorded throughout the Daily organ data collection. Record the most aberrant core temperature from 37.0°C or 98.0 °F observed during the study day. This refers to the temperature which deviates from 37.0°C or 98.0 °F the most.

For example, the following core temperatures were recorded on study day 1: 37.7ºC, 37.9ºC, 36.0ºC, 36.8ºC. A core temperature of 36.0ºC should be recorded in the CRF because it deviates the most from 37.0°C.

To convert a non-core temperature to a core temperature: Oral temperature + 0.5 °C = core temperature Axillary temperature + 1.0°C = core temperature.

MAP Enter the lowest MAP observed during the study day. This value should only be recorded if the patient is NOT receiving any vasopressors (i.e. dopamine, dobutamine, norepinephrine, epinephrine, phenylephrine or vasopressin).

If the patient is receiving vasopressors then enter “N/D” on the CRF.

Respiratory Rate Enter the highest mechanical and/or spontaneous respiratory rate observed during the study day.

Urine output (mL)

Place a √ in the appropriate volume range for urine output for the study day.

Dialysis Indicate whether the patient received any type of dialysis at any point during the study day.

Vasopressors/Inotropes

Record the highest hourly dose infused for each of the following vasopressor/inotropes (in the units requested) received during the study day. Use the following units

Dopamine ( µg/kg/min) Epinephrine ( µg/kg/min) Dobutamine ( µg/kg/min) Phenylephrine ( µg/min) Norepinephrine ( µg/kg/min) Vasopressin (units/min)

Enter “N/D” in the row if no vasopressor/inotropes were administered that day.



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Daily Laboratory Instruction

Duration of Data Collection

These data are to be collected while patient is mechanically ventilated as follows: Daily from Study Day 1 until 10 days post last successful grafting



PaO2/FiO2 Record the lowest PaO2/FiO2 (PF ratio) observed on the study day. The PaO2 and FiO2 values should come from the same blood gas measurement.

T-bilirubin highest

Record the highest serum total bilirubin observed on the study day. Indicate the units the result was recorded in.

Serum Creatinine lowest

Record the highest serum creatinine observed on the study day. Indicate the units the result was recorded in.

BS closest to 08:00

Record the blood sugar closest to 8am observed on the study day 6 hrs (i.e. from 02:00 to 14:00 hrs). Indicate the units the result was recorded in.

Urea highest

Record the highest serum urea observed on the study day. Indicate the units the result was re-corded in.

Albumin highest

Record the highest serum albumin observed on the study day. Indicate the units the result was recorded in.

Lactate highest

Record the highest lactate level observed on the study day. If not available record n/a in the box. Indicate the units the result was recorded in.

Platelets lowest

Record the lowest serum platelets observed on the study day. Indicate the units the result was recorded in.

WBC highest

Record the highest white blood count observed on the study day. If there is only one value recorded for the 24 hr period then record the one value as the highest and lowest. Indicate the units the result was recorded in.

WBC lowest

Record the lowest white blood count observed on the study day. If there is only one value recorded for the 24 hr period then record the one value as the highest and lowest. Indicate the units the result was recorded in.



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General Instructions Duration of Data Collection

These data are collected to determine the adequacy of all types of nutrition (calories and protein received) These data are to be collected daily from Study Day 1 (ICU admission) until 10 days post last successful grafting



Enteral Nutrition Today? Formula Formula Strength Location of feeding tube Total kcals Total Protein Feeds Interrupted

For each day, indicate whether the patient received enteral nutrition, Yes or No. If yes to Enteral Nutrition, using Appendix 3 Enteral Nutrition, choose the number that corresponds to the type of enteral formula received. You may record up to 3 different formulas used in a day. Record the first formula re-ceived in the box numbered “1” and so on. If only one type of enteral formula is received, enter N/D in the 2nd and 3rd boxes. In the event that the patient receives more than 3 formulas in one day, select the 3 that provide the largest volumes. If other formula used, please specify by recording the name of the formula. Record whether the formula strength is full strength (full), half strength (1/2) or any other strength. If there is more than one formula used, separate the strengths by using a forward slash. For example, if the first formula is full strength, the second is half strength and the 3rd is full strength, record as “FS/1.5/FS” Indicate the positon of the feeding tube (either confirmed or estimated) in the appropriate box:

1. Gastric 2. Small bowel (includes post-pyloric, duodenal or jejunal) 3. No tube in place

Record the total calories (kilocalories) and protein from all the enteral nutrition formulas received in the study day. Include the calories and protein from any supplements. Do not include the calories from IV solutions (e.g. Dextrose). Do not record the calories from propofol (volume to be entered separately below). Indicate Yes or No if enteral nutrition was ever interupted today. If yes, select all that apply from the list. 1. Fasting for endotracheal extubation or intubation or other bedside procedure 2. Fasting for operating procedure 3. Fasting for radiology procedure 4. High gastric residual 5. Increased abdominal girth, abdominal distension or pt. discomfort 6. Vomiting or emesis 7. Diarrhea 8. No enteral access available / enteral access lost, displaced or malfunctioning 9. Inotropes, vasopressor requirement 10. Subject deemed too sick to continue enteral feeding 11. Reason for EN interruption not known 12. Other specify_____________________

Parenteral Nutrition today? Total Kcals Total Protein

Indicate whether the patient received parenteral nutrition or not. If yes, record the total calories (kilocalories) and grams of protein received from parenteral nutrition. Do not include the calories from IV solutions (e.g. Dextrose). Do not record the calories from propofol (volume to be entered separately below).

Oral feeding today? Total kcals & Protein

This refers to the calorie (kilocalories) and protein intake from oral feeding only for at least the first week following the discontinuation of enteral feeding. Indicate whether the patient received any oral intake today, Yes, No or Not Done in the event that no calorie/protein intakes were kept.

Propofol today? Total mLs

Indicate whether the patient received a continuous infusion ≥ 6hrs, Yes or No. This is to be completed for each day regardless of whether the patient received enteral nutrition, parenteral nutrition or neither. Record the volume of propopfol received each day (mls)


Daily Nutrition Instruction



Daily Nutrition Page #:_____ √ box if last page of Daily Nutrition

Study Day # DATE dd/mmm/yyyy

No Yes

Formula

↓ Location of feeding tube

Total kcals Total protein gram

No Yes ↓ Total kcals

↓ No Yes Total mL

No Yes

EN today?

PN today?

Other (specify)

Propofol today?

Oral feeding today?

Total kcals

Feeds interrupted today? No Yes ↓

Total protein gram

Total protein gram

Other (specify)

Formula Strength

↓ Not done


No Yes

Formula




↓ No Yes Total mL

No Yes

EN today?

PN today?

Other (specify)

Propofol today?

Oral feeding today?

Total kcals


Total protein gram

Total protein gram

Other (specify)

Formula Strength

↓ Not done


No Yes

Formula




↓ No Yes Total mL

No Yes

EN today?

PN today?

Other (specify)

Propofol today?

Oral feeding today?

Total kcals


Total protein gram

Total protein gram

Other (specify)

Formula Strength

↓ Not done


-


Study Blood Work Instructions


These data are to be collected to determine the effect of the study intervention on mechanistic endpoints (i.e. lymphocyte function, heat shock proteins, inflammatory cytokines, etc) Study blood work is to be drawn on the following days: Draw 1 (4 days post start of study intervention) 48 hrs Draw 2 (7days post start of study intervention) 48 hrs Draw 3 (14 days post start of study intervention) 48 hrs Draw 4 (21 days post start of study intervention) 48 hrs Blood samples are to be drawn from the central line, wherever possible. If there is no central line, then blood should be drawn at the same time as routine blood work to prevent unnecessary blood draws. If there is no central line and there is no routine blood work scheduled for 4, 7, 14 or 21 days post start of study intervention (or the next day if weekend), do not draw blood. Blood samples must NOT be drawn within the period of 12 hrs after surgery or a blood transfusion. It is ok to draw blood before surgery/transfusion. Refer to the Lab Manual for more details.

Date and Time For each day of blood draw, complete the date the study blood work was taken in the format dd-mmm-yyyy and the time in the format of 24 hr clock. Study bloodwork should be drawn at the same time as regular morning blood draw, if possible.

If no blood taken, reason why Please document reason study blood work not completed.

Affix CRF label For each day of blood draw, obtain the Case Report Form Label from the tube kit and affix this label to the appropriate row on the Study Blood Work Case Report Form. Ensure that you have recorded the patient enrollment number in the last 3 spaces on the label.


Study Blood Work

DATE and time sample taken If no study blood work taken, explain why

Draw # 1

Draw # 2

Draw # 3

Draw # 4

D D M M M Y Y Y Y H H M M





-

Affix CRF label from tube kit here





Burn Related Operative Procedures Instructions


These data are collected to determine the frequency and type of burn related operative procedures that the patient undergoes during the study. Record all operations from Study Day 1 (ICU admit) to 10 days post last successful grafting.



Patient had a burn related procedure today Yes or No? Type of Operative Procedure

Indicate Yes or No if the patient had undergone any burn related operating procedures. If Yes Indicate from the taxonomy the type(s) of operation(s) performed that day.

1) Surgical excision (tangential or fascial) 2) Excision and temporary covering (xenograft, allograft and artificial skin) 3) Excison and autograft 4) Delayed autograft 5) Excision and primary closure/composite tissue transfer 6) Other specify—example amputation



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N

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No

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No

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N

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Yes

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No

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N

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es

No

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N

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No

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N

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Yes

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No

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No

Yes

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No

Yes

N

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Blood Products Instructions


These data are collected to capture all blood products the patient received. These data are to be collected on days that blood products were given for the following duration: Daily from Study Day 1 (ICU admit) until 10 days post last successful grafting

No blood products received

If no blood products were received then place a check in the box.

Date Record the date that blood products (Platelets, Packed cells or Fresh Frozen Plasma) given.

Blood Product Indicate which of the following was received by placing a in the appropriate category: Platelets Packed Cells (PC) Fresh Frozen Plasma (FFP) Record the total volume of each of the blood products received by entering the number of units in the spaces provided. Ensure that each type of blood product is recorded on a separate row.




NO BLOOD PRODUCTS RECEIVED

Blood Products

Date Blood Product Volume

Page #:_____ √ box if last page of Administaton of Blood Products


-

Platelets PC FFP Units

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Platelets PC FFP

Units

Units

Units

Units

Units

Units

Units

Units

Units

Units

Units

Units

Units

Units

Units


Concomitant Medication Instructions


These data are collected to capture all relevant medications that the patient received that may have a material effect on the measured outcomes of the study. Record all concomitant medications started from Study day 1 (ICU admit) to 10 days after the last successful grafting.

No concomitant medications were given

If no concomitant medications were given for the duration of the study, then place a check in the box.



Insulin Record the total units received in the 24 hour period from all insulin IV, SC (subcutaneous) and bolus. If no insulin was given put a forward slash through the box.

Sedative and Analgesics

Using Appendix 5 Sedative and Analgesics, choose the medication(s) the patient was receiving for pain sedation. Enter the corresponding number in the first two boxes. Then choose the appropriate route from the taxonomy below and enter the corresponding number into the last box.

1) IV continuous 2) IV intermittent 3) Oral 4) Enteral

Example, patient on IV intermittent Resperidone should be recorded as 34-2

Motility agents Indicate if any of the following motility agents (Maxeran, Erythromycin, Motilium, other) were given, Yes or No.

Oxandralone Indicate if Oxandralone was given, Yes or No.

Propanolol Indicate if Propanolol was given, Yes or No.



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Antibiotic, Antifungal, Antiviral Instructions General Instructions & Duration of Data Collection

These data are collected to assist in determining the incidence of ICU acquired infections. The term “antibiotics” used in this case report form will be used to refer to all antibiotics, antifungals, and antivirals including topical antibiotics, topical antifungals, and antibiotic impregnated dressings. Record all antibiotics daily started from ICU admit time to 10 days after the last successful grafting. If the antibiotic was held for >48 hours and then restarted, then enter it as a new entry. The exception is if drug levels are high (vancomycin) in which case a new entry is not required. Do not record antibiotics started after ICU discharge Do not record antibiotics ordered but never received Do not record any changes in dose/route/frequency as a separate entry.

No Antibiotics given If no antibiotics were ever given then place a check in the box on the upper left hand corner.

Entry # This refers to the sequential number of antibiotics that the patient received. Record the first antibiotic received after ICU admission as A-01. The next antibiotic is to be recorded as A-02 and subsequent antibiotics are to be numbered sequentially. This sequential numbering is to ensure that the infection adjudication forms are filled accurately.

Start Date and Time Complete the date and time the antibiotic was actually given (i.e. not when the order was written) in the date format of dd-mmm-yyyy and time format of the 24 hr clock.

Antibiotic Name From Appendix 4 Antibiotics choose the number that corresponds to the antibiotic prescribed.

Dose Record the dose of antibiotics given.

Unit Record the appropriate units given from the list below mg g units

Route Record the appropriate route given from the list below. IV PO/NG IM Topical (includes topical antibiotics/antifungals, durable silver membranes, and impregnated dressings)

Frequency Record the appropriate frequency given from the list below. OD q__hrs BID TID QID

Stop Date and Time Complete the date and time the antibiotic was actually stopped in the date format of dd-mmm-yyyy and time format of the 24 hr clock.

Suspicion of ICU acquired infection questions

To help determine the suspicion of an ICU acquired infection, the following question must be answered: “Was this antibiotic started after 72 hours of admission to ICU?” If the response is NO, no adjudication is needed and you do not complete the infection adjudication form for this antibiotic. If the response is yes, for each antibiotic started, the following two questions must be answered: 1) Is this antibiotic given for prophylaxis? If there is a change in type of prophylactic topical antibiotic creams/antibiotic impregnated dressings for the purpose of treating presumptive or a proven wound infection, the response to this question should be NO. For antibiotics given for empiric treatment, the response to this question should be NO. 2) Is this a substitute for an antibiotic previously ordered for an infection that occurred within the first 72 hours of ICU admission? Examples: When stepping down from an IV antibiotic such as Ceftriaxone to a po antibiotic i.e. Cefuroxime or Ciprofloxacin, the answer to this question should be YES. When switching from IV Ceftrioxime that was started in the first 72 hrs to a broad spectrum antibiotic i.e. IV Meropenem due to worsening infection, the answer to this question should be NO. If the response is yes to either one, no adjudication is needed and you do not complete the infection adjudication form for this antibiotic. If the response is no to both, proceed to the infection adjudication form and instructions. Since the responses to these questions have a material affect on the presence of a newly acquired ICU infection, these questions MUST be answered by the Site investigator/MD delegate.


Page #:_____ √ box if last page



-

Antibiotics, Antifungals and Antivirals Page #:_____ √ box if last page of Antiobiotic Therapy

NO ANTIOBIOTICS GIVEN

Dose Unit Route Frequency Suspicion of Infection Questions

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

(24 hour clock)

H H M M D D M M M 2 0 Y Y

Stop date and time

Start date and time

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

(24 hour clock)

H H M M D D M M M 2 0 Y Y

Stop date and time

Start date and time

Entry number A

Entry number A

Antibiotic name

Other (specify)

Antibiotic name

Other (specify)

Substitute for antibiotic previously ordered for an infection within 72 hrs of ICU admission?

Was antibiotic given for prophylaxis? Yes No

Yes No

Was this antibiotic started > 72 hours from ICU admission?

Yes No Adjudication NOT required for this entry number.

Answer the two questions below.

If you answered NO to both questions proceed to the adjudication form and refer to this entry number.

Page 37

Substitute for antibiotic previously ordered for an infection within 72 hrs of ICU admission?

Was antibiotic given for prophylaxis? Yes No

Yes No

Was this antibiotic started > 72 hours from ICU admission?

Yes No Adjudication NOT required for this entry number.

Answer the two questions below.

If you answered NO to both questions proceed to the adjudication form and refer to this entry number.

Page 37


Microbiology Instructions

General Instructions & Duration of Data Collection

These data are collected to assist in determining the incidence of ICU acquired infections. Record all positive cultures collected from the ICU admit date and time to 10 days post last successful grafting. Do not record routine surveillance swabs or cultures. Exception: if a swab was done for a clinical

reason, i.e. an abscess and it is positive then record it. But do not record surveillance swabs for VRE or MRSA.

Do not record cultures that are considered to be a contaminant or reported as No growth or Common Mixed Flora EXCEPT for blood cultures. Record all growth from blood cultures regardless of whether you think that this is a contaminant or not.

Record one sample (culture) and up to 6 organisms from the same sample per page .

Entry # This refers to the sequential number of the positive culture for the patient. Record the first sample taken after ICU admission that was positive as M-01. The next positive culture is to be recorded as M-02 and subsequent positive cultures are to be numbered sequentially. This sequential numbering is to ensure that the infection adjudication forms are filled accurately.

Date and Time Complete the date and time the sample was collected (i.e. not when the results were reported) in the date format of dd-mmm-yyyy and time format of the 24 hr clock.

Sample Type From the taxonomy choose the number that corresponds to the sample type. 1) Sputum expectorated 6) Blood 2) Nasotracheal/Endotracheal/Tracheal aspirate 7) Tissue or burn wound culture 3) Bronchoscopy specimen protected brush 8) Urine 4) Bronchoalveolar lavage (BAL) 9) Pleural fluid 5) Bronchial washing 10) Other (please specify)

Organism # Record all the pathogens reported in the hospital microbiology report. For the first organism documented in the report, in the boxes after Organism #1, record the number corresponding to the documented organism from Appendix 6 Microbiology Organisms. If “other” is to be selected, write the organism in the space provided. Continue to record all subsequent organisms sequentially in the boxes after Organism #2, Organism #3, etc. Use the supplemental form (#35a) if more than 3 organisms are reported.

Quantitative Results

If applicable record the colony forming units (cfus) reported as: 1) >104 cfu/ml or > 107 cfu/L 5) <105 cfu/g 2) <104 cfu/ml or < 107 cfu/L 6) None reported 3) >15 cfu/ml 7) Other specify 4) >105 cfu/g

Suspicion of ICU acquired infection questions

For each organism that grows from the positive culture, the following question must be answered: “Is this organism a manifestation of an infection that occurred within the first 72 hrs of ICU admission?” If the response is yes, choose one of the following: Relapse/Recurrent (an infection in which the microorganism was present on the initial culture, was eradicated and then the same organism that was responsible for the initial infection returns) OR Persistent (an infection in which the microorganism that was present on the initial culture persists on subsequent cultures). Do not proceed to the infection adjudication form for this organism. Proceed to enter further organism data for this culture. If the response is no, proceed to the infection adjudication form/instructions and proceed to complete any further organism data for this culture. Since the responses to these questions have a material affect on the presence of a newly acquired ICU infection, the responses to these questions MUST be provided by the Site investigator/delegate.


Was sample taken after 72 hrs of ICU admission?

To help determine the suspicion of an ICU acquired infection, the following question must be answered: “Was this sample taken after 72 hours of admission to ICU?”. If the response is no, no adjudication is needed and you do not complete the infection adjudication form. Complete the right hand side column for organism data for this culture. If the response is yes, complete the left hand side column for organism and other data for this culture.



Microbiology Page #:_____ √ box if last page of Microbiology

Entry number M

D D M M M 2 0 Y Y

(24 hour clock)

H H M M Date and time sample was taken

Sample type Other (specify)

Organism #1 Other (specify)





-



See Appendix 6 See Appendix 6



Was this sample taken >72 hours from ICU admission? If No, complete this column below. There is no suspicion of a newly acquired infection and no adjudication is needed If Yes, Complete this column below


Other (specify)


Other (specify)


Other (specify)


Other (specify)

If No, proceed to the adjudication form and refer to this entry number and organism number

Is this organism a manifestation of an infection that occurred within the first 72 hrs of ICU admission?

Yes

No

If Yes, choose one of the following Yes Relapse/Recurrent

Persistent


Other (specify)



Yes

No


Persistent


Other (specify)



Yes

No


Persistent

Page 37

Page 37

Page 37

n/a

n/a

n/a

n/a



Entry number M

D D M M M 2 0 Y Y

(24 hour clock)








-








Other (specify)


Other (specify)


Other (specify)


Other (specify)



Yes

No


Persistent


Other (specify)



Yes

No


Persistent


Other (specify)



Yes

No


Persistent

Page 37

Page 37

Page 37

n/a

n/a

n/a

n/a

a



Entry number M

D D M M M 2 0 Y Y

(24 hour clock)








-








Other (specify)


Other (specify)


Other (specify)


Other (specify)



Yes

No


Persistent


Other (specify)



Yes

No


Persistent


Other (specify)



Yes

No


Persistent

Page 37

Page 37

n/a

n/a

n/a

n/a

a


Infection Adjudication Instructions General Instructions & Duration

These data are collected to determine whether the identified clinical suspicion is a newly acquired infection (after 72 hrs of admission to ICU) or not. A suspicion of infection is determined by the antibiotics received and data on positive cultures. All antibiot-ics and cultures that lead to a suspicion of infection will have been recorded on the previous antibiotics and microbiology case report forms and these entry numbers are to be transferred to this Adjudication form. All suspicions of infections, identified by antibiotics and/or positive cultures MUST be adjudicated. This adjudication MUST be done by the Site Investigator/MD delegate while the Research Coordinator is responsible for recording the data.

Suspicion # Date

Record the # of the suspicion of infection sequentially i.e. the first suspicion of infection for the patient is to be recorded as 01, the next is to be recorded as 02 and so on. Record the date of the clinical suspicion of infection in the dd/mmm/yyyy format. As a general guideline, antibiotics started within 24-48 hrs of a positive culture and vice versa may be considered for the same clinical suspicion of an infection. In this event, the date of the clinical suspicion is either the start of the antibiotics or the date of the culture taken, whatever occurred first.

Antibiotic Entry # List all the antibiotic entry numbers (A-2 digits) that are related to this clinical suspicion from the Antibi-otic, Antifungal, Antiviral form. These are the antibiotics for which the response for both the following ques-tions was NO: 1) Was this antibiotic given for prophylaxis? and 2) Is this antibiotic a substitute for an antibiotic previously ordered for an infection that occurred within 72

hrs of ICU admission? The entry # is the 2 digit # following the A on the Antibiotic form i.e. 01, 02, 03: If there are no antibiotics that relate to this suspicion (only positive cultures), tick the box titled “NO related antibiotics”

Microbiology Entry #

List all the microbiology entry numbers(M-2 digits) from the top left hand corner of the Microbiology Form and all the organism numbers (# 1, #2, #3, etc) that are related to this clinical suspicion. These are the organisms for which the response for the following questions was NO: “Is this organism a manifestation of an infection that occurred within the first 72 hrs of ICU admission?” The Microbiology entry # is the 2 digit # following the M on the Microbiology form: The organism # is the sequential # of the organism on the Microbiology form i.e. 1,2,3. It is not the 1-3 digit number from Appendix 6. If there are no organisms that relate to this suspicion (only antibiotics), tick the box titled “NO related cultures”

Adjudication For each of the clinical suspicions, which have been triggered by the antibiotic and/or culture data, the Site Investigator/MD must determine if there is an infection or not, by choosing one of the following six options: 1) Previously Adjudicated: if this suspicion has already been adjudicated. If so, record the Suspicion # that this adjudication was done for. 2) Definite Yes 3) Probably Yes 4) Possible Yes 5) Probable No 6) Possible No

Follow all these instructions for the antibiotics and positive cultures that relate to the next suspicion of infection and so on. Refer to the Implementation Manual for more details.


Refer to Appendix 7. Categories of Infection. Pick the appropriate category of infection and record in the category column

Refer to Appendix 8. Definition of No Infection.

0 Entry number 1 A


0 Entry number 1 M

Ver

sion

: S

ept 1

0, 2

010

37

In

fect

ion

Adj

udic

atio

n

Site

Num

ber

Enr

ollm

ent #

-

Pag

e #:

____

_

√ bo

x if

las

t p

age

of

Ad

jud

icat

ion

Ant

ibio

tic

Mic

robi

olog

y A

djud

icat

ion

Cat

egor

y

Sus

pici

on #

D

ate

of c

linic

al s

uspi

cion

of i

nfec

tion

Sus

pici

on #

Dat

e of

clin

ical

sus

pici

on o

f inf

ectio

n

Sus

pici

on #

Dat

e of

clin

ical

sus

pici

on o

f inf

ectio

n

List

all

the

entr

y nu

mbe

rs o

f the

ant

ibio

tics

that

are

re

late

d to

the

clin

ical

sus

pici

on o

f inf

ectio

n.

List

all

the

entr

y nu

mbe

rs o

f the

ant

ibio

tics

that

are

re

late

d to

the

clin

ical

sus

pici

on o

f inf

ectio

n.

List

all

the

entr

y nu

mbe

rs o

f the

ant

ibio

tics

that

are

re

late

d to

the

clin

ical

sus

pici

on o

f inf

ectio

n.

List

the

entr

y/or

gani

sm n

umbe

rs o

f all

the

cultu

res

that

are

re

late

d to

the

clin

ical

sus

pici

on o

f inf

ectio

n.

List

the

entr

y/or

gani

sm n

umbe

rs o

f all

the

cultu

res

that

are

re

late

d to

the

clin

ical

sus

pici

on o

f inf

ectio

n.

List

the

entr

y/or

gani

sm n

umbe

rs o

f all

the

cultu

res

that

are

re

late

d to

the

clin

ical

sus

pici

on o

f inf

ectio

n.

P

roba

ble

No

Pos

sibl

e N

o

Def

inite

Yes

P

roba

ble

Yes

P

ossi

ble

Yes

Pre

viou

sly

ad

judi

cate

d

P

roba

ble

No

Pos

sibl

e N

o

Def

inite

Yes

P

roba

ble

Yes

P

ossi

ble

Yes

P

roba

ble

No

Pos

sibl

e N

o

Def

inite

Yes

P

roba

ble

Yes

P

ossi

ble

Yes

No

rela

ted

antib

iotic

s N

o re

late

d cu

lture

s

A

A

A

A

A

A

A

A

A

A

A

A

A

A

A

A

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

No

rela

ted

cultu

res

No

rela

ted

antib

iotic

s

A

A

A

A

A

A

A

A

A

A

A

A

A

A

A

A

No

rela

ted

cultu

res

No

rela

ted

antib

iotic

s

Sus

pici

on #

____

Pre

viou

sly

ad

judi

cate

d S

uspi

cion

#__

__

D

D

M

M

M

2 0

Y

Y

D

D

M

M

M

2 0

Y

Y

D

D

M

M

M

2 0

Y

Y

A

A

A

A

A

A

A

A

A

A

A

A

A

A

A

A

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-

M

-


General Instruc-tions Duration of Data Collection

These data are collected to determine clinical outcomes related to length of stay, duration of ventilation and mortality. These data are to be collected once.

Mechanical Ventilation Stop

If the patient received invasive mechanical ventilation, place a check in Yes box and record the final stop date and time that mechanical ventilation was discontinued. Do not record episodes of temporary ventilation (defined as <48 hrs i.e. needed for operating procedures, etc) For patients that are on and off the ventilator, the patient is considered to be ventilator free if they are successfully breathing without mechanical ventilation for > 48 hours. In this event, record the date and time the ventilation was actually discontinued (i.e. in this instance, the start of the 48 hrs). Patients will be considered breathing without mechanical ventilation in any of these instances:

extubated and on face mask (nasal prong) intubated or breathing through a t-tube tracheostomy mask breathing. continuous positive airway pressure (CPAP) <=5cmH2O without pressure support or intermittent mandatory ventilation assistance.

If patient is transferred out of the ICU to another institution and is still receiving mechanical ventilation then record the transfer date and time as the mechanical ventilation discontinuation date and time. Place a check in the No box if the patient never received invasive mechanical ventilation and proceed to the Death section.

Mechanical Ventilation start #2

In the event that the patient is restarted on invasive mechanical ventilation after being extubated successfully for 48 hrs, place a check in Yes box. Record the date and time invasive mechanical ventilation was restarted in the Mechanical Ventilation start #2 row. If patient never restarted invasive mechanical ventilation, then tick the NO box and proceed to the Death section row.

Mechanical Ventilation stop #2

Record the date and time the invasive mechanical ventilation episode recorded in Mechanical Ventilation start #2 row was discontinued.

Mechanical Ventilation start #3 and Mechanical Ventilation stop #3

Follow the instructions as listed for Mechanical Ventilation start # 2 and stop # 2 for the third episode of mechanical ventilation, if applicable.

Dialysis If you have entered yes to dialysis on the Daily Organ Dysfunction form (pg 19) please answer the following.

The first time dialysis was started, was it due to acute renal failure?

The first time dialysis was started, was it due to acute renal failure? If Yes, continue to the next question. If No, the dialysis section is complete.

Dialysis Stop Record the date and time dialysis was permanently discontinued in the hospital. This may occur on the ward. If patient is discharged from hospital or transferred out of the ICU to another institution and is still receiving dialysis, check the box “ Continued past hospital discharge”. At 6 months if patient is still on dialysis in hospital, check the box “At 6 months still on dialysis in hospital”

Invasive Mechanical Ventilation / Dialysis


Invasive Mechanical Ventilation / Dialysis


-

Date Time

Mechanical Ventilation stop

Mechanical Ventilation start # 2

Mechanical Ventilation stop # 2

Mechanical Ventilation start # 3

Mechanical Ventilation stop # 3

D D M M M 2 0 Y Y

(24 hour clock)

H H M M Pt received invasive mechanical

ventilation?

Pt restarted invasive mechanical ventilation? D D M M M 2 0 Y Y

(24 hour clock)

H H M M

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

Yes

No Go to Death Section

Pt restarted invasive mechanical ventilation?

Yes


Yes


2 0 D D M M Y Y

(Continue to next row) Yes No (Stop here)


Continued past hospital discharge At 6 months, still on dialysis in hospital

Dialysis If you have entered yes to dialysis on the Daily Organ Dysfunction form (pg 19) please proceed below.

The first time dialysis was started, was it due to acute renal failure?

Stop Date


OR OR



These data are collected to determine survival at the 6 month follow up interval. Survival assessment is to be conducted at 6 months ( 14 days) from ICU admission. If a subject can’t be reached to obtain the information, efforts must be made to obtain this information from the next of kin/hospital records.

Date of contact Record the date of contact with the patient, family member, physician or other means to assess survival status.

Survival Status Choose one of the options below: 1) Alive 2) Deceased 3) Lost to Follow-up

Date last known to be Alive or Date of Death

If survival status is “alive or lost to follow-up”, record the date the patient was last known to be alive. If the patient is deceased, record the date of death.


These data are collected to determine clinical outcomes related to length of stay, duration of ven-tilation and mortality. These data are to be collected once.

Death If the patient died, tick the Yes box and record the date and time of death. The death date and time is the ones documented on the death certificate. If this information is not available, record the date and time from the physician note. If the latter is not provided, record the date and time documented in the nurse’s charting. If No, tick the NO box , leave the date and time fields blank and proceed to ICU discharge row.

ICU discharge If the ICU discharge is not the same as the death date and time, tick the NO box and enter the date and time the patient was actually discharged from the ICU. If Yes, tick the box, leave the date and time fields blank and proceed to the Hospital discharge row. If the patient dies in ICU, the ICU discharge, Hospital discharge and Death date/time must all be the same.

Hospital discharge If the hospital discharge is the same as the death date and time, tick the NO box and enter the date and time the patient was actually discharged from hospital. For patients who are discharged to a Rehabilitation ward within the institution, the date and time the patient is discharged from the hospital to the Rehabilitation ward is the hospital discharge date and time. IF Yes, tick the box and leave the date and time fields blank. If the patient dies in the hospital, Hospital discharge and Death date/time must be the same.

Discharged to Place a √ in the box that applies to the location of the patient at hospital discharge.

Cause of Death Document the cause of death from a post mortem report. If this is not available, record cause of death from the death certificate.

Follow-Up (6 Months) Instructions

Hospitalization Overview Instructions


D D M M M Y Y Y Y

Date of Contact Survival Status

Date last known to be alive or date of death

D D M M M Y Y Y Y Alive

Deceased

Lost to follow-up


-

Follow-Up (6 Months)

Hospitalization Overview Date Time

Death

ICU Discharge

Hospital Discharge

Discharge to

D D M M M 2 0 Y Y

(24 hour clock)

H H M M Did the patient die?

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

D D M M M 2 0 Y Y

(24 hour clock)

H H M M

ICU discharge same as death date and time?

Hospital discharge same as death date and time?

Yes

No

No

Yes

No

Yes

Ward in another hospital

ICU in another hospital Home

Long term care facility

Rehabilitation Unit

Other specify_____________________

Cause of death: _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________


Comments Instructions

General Information The Comments Form serves to capture extra information that is felt to be pertinent to data already collected in the CRF.

The Comments Form may also be used for any problems/issues related to data collection.

If no comments are recorded check the appropriate box.

Comment Date Record the date (dd/mmm/yyy) when you are making the comment entry into the CRF.

Form Indicate which CRF form type the comment pertains to (e.g. APACHE, Microbiology).

Comment Details Provide a brief explanation.


Example The decision to withdraw life sustaining therapies was made on March 8, 2010 @ 1300 hrs, as noted in the medical chart. As a result, mechanical ventilation was discontinued. A documented time of mechanical ventilation discontinuation can not be found in the medical records and hence is missing from the CRF.

Nursing note indicates decision to withdraw care made at 1300 hrs. Actual time of MV d/c not in chart.

Hospital-zation Overview

0 8 M a r 1 0



Comments

Comment Date Form Comment details

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

M D D M M 2 0 Y Y

Page #:_____ √ box if last page of Comments

CHECK IF NONE


-


Investigator Confirmation Instructions


When all the data collection has been completed, including infection adjudication and hospitalization overview, the Site Investigator is to sign & date the Investigator Confirmation Form to attest to the following: The data collection was conducted under his/her supervision according to the protocol The data and statement, including hospital acquired infection, are complete and accurate to

the best of their knowledge. Following sign-off by the Investigator, the Research Coordinator will copy each completed Case Report Form (odd pages only starting from page 11-45) and mail the originals to CERU (including the Investigator Confirmation Form) using the self-addressed, stamped envelopes provided:

Rupinder Dhaliwal Clinical Evaluation Research Unit Angada 4 76 Stuart Street Kingston General Hospital Kingston, ON K7L 2V7


Investigator Confirmation Form

The data collected in the RE-ENERGIZE Case Report Forms were collected in accordance with the study protocol and established procedures. The data was collected under my supervision. The data and statement, including hospital acquired infection adjudication are complete and accurate to the best of my knowledge.

M D D M M 2 0 Y Y

Full Name of Investigator

Signature of the Investigator


-

Original completed Case Report Forms are attached


Protocol Violation Instructions

Protocol Violation Definition Incident Reports

A Protocol Violation is defined as non-compliance with the study protocol and/or proce-dures that may impact study participant safety, the integrity of study data and/or study participant willingness to participate in the study. For THE RE-ENERGIZE Study, a Protocol Violation occurs when any of the following have occurred: 1) Investigational Product (IP) Daily dose delivered is < 80% prescribed. Example: if the daily dose is 5 packages and the daily dose delivered is less than 4 packets (80%), this is a protocol violation. 2) IP dispensing/dosing error 3) Accidental unblinding of IP 4) Enrollment of a patient that does not fulfill inclusion/exclusion criteria 5) Unapproved procedures performed All unanticipated problems involving risk to subjects or others participating in the study MUST be reported to the Project Leader for reporting to the Department of Defense. These are to be reported as Incident Reports.


Complete Protocol Violation forms on a prospective basis and fax a copy to the Project Leader at (613) 548-2428.

When to report Protocol violations and incidents are to be reported from randomization until end of the study duration (10 days post last successful grafting). Protocol Violations that relate to the <80% dosing delivered do NOT have to be reported on the following days: 1) Day of randomization 2) Day of discharge or end of study treatment (7 days post last successful grafting) 3) Day of death

Date Violation/incident Occurred/Discovered

Enter the date when the violation/incident occurred. Enter the date when the violation/incident was identified by site research staff.

Local Investigator Aware?

Indicate whether the local qualified investigator has been made aware of this violation/incident, Yes or No.

Type of violation or incident

Using the options provided, check the box for the type of violation/incident: Dose delivered is <80% prescribed (according to # packets given). Dispensing/dosing error (an incorrect dose/product was given to patient) Accidental unblinding (the integrity of the study blind has been compromised) Enrollment of a patient that does not fulfill inclusion/exclusion criteria Unapproved procedures performed (failure to obtain consent, taking blood draw on an ex-

tra day, etc) Other, please specify (briefly describe the type of protocol violation) Incident Reports (involves risk to subjects or others participating in the study)

Reason for the Violation

Check the appropriate box and briefly describe the reason for the violation on the lines provided. Describe the circumstances surrounding these violations.

Action taken by Research Coordinator

Describe the action taken by the Research Coordinator/responsible delegate to prevent violation/problem from recurring.




Protocol Violation/Incident Form


-

7. Action taken by Research Coordinator/Responsible Delegate Feeding protocol reviewed, RN education, REB notification, Note To File, etc... ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________

3. Is the local site investigator aware of the violation/incident Yes No

2. Date violation/incident discovered

1. Date violation/incident occurred

For CERU use only:

D D M M M 2 0 Y Y

D D M M M 2 0 Y Y

6a. High gastric residual volumes

6b. Bowel perforation/obstruction 6c. Held for procedure/OR

6. Reason for violation (check all that apply)

6d. Other, specify details or attach Note to File/ Incident Report:_______________________ —————————————————————— ——————————————————————

5. Incident Report 4. Violation 4a. Dose delivered is <80% prescribed:

____ of ____ packets received

4c. Accidental unblinding

4f. Other, please specify: _______________________________________ _______________________________________

4b. Dispensing/Dosing error

4d. Enrollment of ineligible patient

4e. Unapproved procedures performed

Unanticipated problems (involving risk to subjects or others participating in the study) Please specify: _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________ _________________________________________

Are you reporting a Protocol Violation or an Incident Report? (Please check the appropriate section)

D D M M M 2 0 Y Y Date reviewed

Reviewed by;:_____________________________________

Yes No Further action required

Action to be taken: _________________________________ _________________________________________________

Page #:_____ √ box if last page of Protocol Violation


APPENDIX 1

Lund-Browder Diagram


0. NONE MYOCARDIAL 1. Angina 2. Arrhythmia 3. Valvular 4. Myocardial infarction 5. Congestive heart failure (or heart disease) VASCULAR 6. Hypertension 7. Peripheral vascular disease or claudication 8. Cerebrovascular disease (Stroke orTIA) PULMONARY 9. Chronic obstructive pulmonary disease (COPD,

emphysema) 10. Asthma NEUROLOGIC 11. Dementia 12. Hemiplegia (paraplegia) 13. Neurologic illnesses (such as Multiple sclerosis or

Parkinsons) ENDOCRINE 14. Diabetes Type I or II 15. Diabetes with end organ damage 16. Obesity and/or BMI > 30 (weight in kg/(ht in meters)2 RENAL 17. Moderate or severe renal disease

GASTROINTESTINAL 18. Mild liver disease 19. Moderate or severe liver disease 20. GI Bleeding 21. Inflammatory bowel 22. Peptic ulcer disease 23. Gastrointestinal Disease (hernia, reflux) CANCER/IMMUNE 24. Any Tumor 25. Lymphoma 26. Leukemia 27. AIDS 28. Metastatic solid tumor PSYCHOLOGICAL 29. Anxiety or Panic Disorders 30. Depression MUSKOSKELETAL 31. Arthritis (Rheumatoid or Osteoarthritis) 32. Degenerative Disc disease (back disease, spinal

stenosis or severe chronic back pain) 33. Osteoporosis 34. Connective Tissue disease MISCELLANEOUS 35. Visual Impairment (cataracts, glaucoma, macular

degeneration 36. Hearing Impairment (very hard of hearing even with

hearing aids)

APPENDIX 2 COMORBIDITIES


APPENDIX 3 ENTERAL NUTRITION FORMULAS

Code Formula Name Code Formula Name 1 Ensure 48 Nutren 1.5 2 Ensure Fibre 49 Nutren 2.0 3 Ensure HP 50 Nutren Glytrol 4 Ensure Plus 51 Nutren Renal 5 Ensure Prebiotics 52 Nutren Pulmonary 6 Glucerna 53 Nutren Replete 7 Glucerna Select 54 Nutren Replete Fiber 8 Jevity 55 Nutrihep 9 Jevity 1 Cal 56 Peptamen

10 Jevity 1.2 Cal or Jevity Plus 57 Peptamen 1.5

11 Jevity 1.5 Cal 58 Peptamen DT 12 Nepro 59 Peptinex 1.0 13 Osmolite 1 Cal 60 Peptinex 1.5 14 Osmolite 1.2 Cal 61 Peptamen with Prebio 1 15 Osmolite 1.5 Cal 62 Peptamen AF 1.2 16 Osmolite with Fiber 63 Renalcal 17 Osmolite HN 64 Resource 2.0 18 Osmolite HN Plus 65 Resource Diabetic 19 Osmolite High Protein 66 Resource Standard 20 Oxepa 67 Supplements- Beneprotein Instant Protein Powder 21 Optimental 68 Supplements - Microlipid 22 Promote 69 Supplements – Resource Benecalorie 23 Promote with Fiber 70 Supplements - MCT Oil 24 Pulmocare 71 Supplements- Resource Benefiber 25 Suplena 72 Traumacal 26 Two Cal HN 73 Baxter: Restore-X 27 Vital 74 MEAD JOHNSON: Portagen 28 Vital HN 75 Hormel Health: Propass 29 Supplement: Polycose powder 76 National Nutrition: Prosource liquid 30 Supplement: Polycose Liquid 77 National Nutrition: Prosource powder 31 Supplement: Promod 78 Global Health: Procel 32 Supplement: Prosure 79 Medical Nutrition: Pro-stat 33 Boost 1.0 Standard 80 Wyeth: Enercal 34 Boost 1.5 Plus Calories 81 Wyeth: Enercal Plus 35 Compleat 82 Other Nutritional Formula specify 36 Diabetisource AC 37 Fibersource 38 Fibersource HN 39 Isosource 40 Isosource HN 41 Isosource HN with fibre 42 Isosource VHN 43 Isosource 1.5 Cal 44 Novasource Renal 45 Novasource Pulmonary 46 Nutren 1.0 47 Nutren 1.0 Fiber


APPENDIX 4 ANTIBIOTICS

1 Acyclovir 39 Cloxacillin 77 Ofloxacin

2 Amantadine 40 Cycloserine 78 Olsetamivir 3 Amikacin 41 Diamino-diphenyl sulphone 79 Oxacillin 4 Aminosalicylic acid 42 Dicloxacillin 80 Penicillin

5 Amoxicillin 43 Dimenocycline 81 Pentamidine

6 Amoxicillin/clavulinic acid 44 Doxycycline 82 Piperacillin

7 Amphotericin B 45 Ertapenem 83 Piperacillin/Tazobactem

8 Ampicillin 46 Erythromycin 84 Polimyxin B

9 Ampicillin/sulbactam 47 Ethambutal 85 Polimyxin E

10 Anidulafungin 48 Ethionamide 86 Primaquin

11 Anti-HIV therapy-please name: 49 Famcyclovir 87 Pyrazinamide

12 Azithromycin 50 Fusidic Acid 88 Quinopristin+ Dalfopristin

13 Aztreonam 51 Fluconazole 89 Ribavirin

14 Bacitracin 52 Flucytosine 90 Rifabutin

15 Capreomycin 53 Foscarnet 91 Rifampin

16 Carbenicillin 54 Fosfomycin 92 Rimantadine

17 Caspofungin 55 Ganciclovir 93 Spectinomycin

18 Cefaclor 56 Gatifloxacin 94 Streptomycin

19 Cefamandole 57 Gentamicin 95 Sulfadiazine

20 Ceftazidime 58 Imipenem/Cilastatin 96 Sulfamethoxazole

21 Cefazolin 59 Isoniazid 97 Sulfisoxazole

22 Cefepime 60 Itraconazole 98 Teicoplanin

23 Cefixime 61 Kanamycin 99 Telithromicine

24 Cefoperazone 62 Ketoconazole 100 Temocillin

25 Cefotaxime 63 Levofloxacin 101 Tetracycline

26 Cefotetan 64 Linezolid 102 Ticarcillin

27 Cefotiam 65 Meropenem 103 Ticarcillin/clavulinic acid

28 Cefoxitin 66 Metronidazole 104 Tigecycline

29 Cefprozil 67 Mezlocillin 105 Tobramycin

30 Ceftriaxone 68 Micafungin 106 Trimethoprim

31 Cefuroxime 69 Minocycline 107 Trimethoprim-Sulfamethoxazole (Cotrimoxazole)

32 Cephalexin 70 Moxyfloxacin 108 Trovofloxacin

33 Cephalothin 71 Nafcillin 109 Valacyclovir 34 Ciprofloxacin 72 Nalidixic Acid 110 Valganciclovir 35 Clarithromycin 73 Netilmycin 111 Vancomycin

36 Clindamycin 74 Nitrofurantoin 112 Voriconazole

37 Clofazimine 75 Norfloxacin 113 Zanamavir

38 Cloramphenicol 76 Nyastatin 114 OTHER: please specify


APPENDIX 4 con’t

ANTIBIOTICS

Topical Antibiotics Petrolatum based ointments 115 Bacitracin-petrolatum 116 Bacitracin/polymyxin-petrolatum 117 Bacitracin/polymyxin/Neomycin-petrolatum 118 Mupiricin 119 OTHER: Petrolatum based ointments speify Water Based ointments 120 Silver Sulfadizene cream 121 Sulfamylon Cream 122 Sulfamylon 5% solution 123 AgN03 0.5% solution 124 Silvabsorb Gel

125 OTHER: water based ointments specify Durable Silver Membranes

126 Aqucel AG (hydrocellulose-Silver chloride dressing)

127 Acticoat 3 128 Acticoat 7 129 Acticoat flex 130 Acticoat absorbent dressing 131 Mepilex AG 132 Silverlon and Silver seal 133 OTHER: Durable Silver membranes Topical Antifungals 134 Topical Nystatin 135 Topical Amphotreicin 136 OTHER: topical antifungal specify Antibiotic Impregnated Dressings 137 Sulfamylon 5% solution w/ Amphotreicin solu-

tion on lap pads for dressings

138 OTHER: antibiotic impregnated dressings spec-ify


APPENDIX 5

SEDATIVES AND ANALGESICS

Antihistamines Benzodiazepines con’t

Other

1 Chloral Hydrate 28 Quazepam (US only) Opioid partial agonists:

2 Dimenhydrinate 29 Temazepam 52 Buprenorphine

3 Diphenhydramine 30 Triazolam 53 Pentazocine

4 Doxylamine Non-Benzodiazepine "Z-drugs" sedatives

54 Ketamine

5 Promethazine 31 Eszopiclone 55 Paracetamol Barbiturates 32 Haloperidol 56 Toradol 6 Amobarbital 33 Olanzapine 57 OTHER:specify

7 Butabarbital 34 Quetiapine

8 Butorphanol 35 Respirdone

9 Methohexital 36 Zaleplon

10 Nalbuphine 37 Zolpidem

11 Pentobarbital 38 Zopiclone

12 Phenobarbitol

Opiates Opioid agonists:

13 Primidone 39 Alfentanil

14

Secobarbital 40 Codeine (also combina-tions products: Codeine + acetaminophen + caf-feine; codeine + ASA + caffeine)

15 Thiopental 41 Fentanyl

Benzodiazepines 42 Hydrocodone

16 Alprazolam 43 Hydromorphone

17 Bromazepam 44 Levorphanol (U.S. only)

18 Chlordiazepoxide 45 Meperidine

19 Clonazepam 46 Methadone

20 Clorazepate 47 Morphine

21 Diazepam 48 Oxycodone

22 Estazolam 49 Oxymorphone (U.S. only)

23 Flurazepam 50 Propoxyphene

24 Lorazepam 51 Sufentanil

25 Midazolam

26 Nitrazepam

27 Oxazepam


APPENDIX 6 MICROBIOLOGY ORGANISMS

Bacteria Bacteria (con’t) Acinetobacter sp. 1a baumani Clostridium sp. 17a botulism 1b Other specify 17b difficile Actinomyces sp. 2 Other specify 17c perfringes Aerococcus sp. 3 Other specify 17d septicum Aeromonas sp. 4a aerogenes 17e tetani 4b Other specify 17f Other specify Alcaligenes sp. 5a dentrificans Corynobacterium sp. 18 Other specify 5b foecalis Coxiella sp. 19a burnetti 5c xylosodidans 19b Other specify 5d Other specify Diphteroids sp. 20 Other specify Babesia sp. 6 Other specify Ehrlichia sp. 21 Other specify Bacillus sp. 7a anthracis Eikenella sp. 22a corrodens 7b Other specify 22b Other specify Bacteroides sp. 8a fragilis Enterobacter sp. 23a aerogenes 8b thetaiotamicron 23b cloacae 8c Other specify 23c Other specify Bartonella sp. 9 Other specify Enterococcus sp. 24a avium Borrellia sp. 10a burgdoferi 24b fecalis 10b Other specify 24c foecium Bortetella sp. 11a pertussis 24d Other specify 11b Other specify Erysipelothrix sp. 25a rhusiopatheia Burkholderia sp. 12a cepacia 25b Other specify 12b mallei Escherichia sp. 26a coli 12c pseudomallei 26b Other specify 12d Other specify Francisella sp. 27a tularensis Campylobacter sp. 13a fetus 27b Other specify 13b jejuni Fusobacterium sp. 28 Other specify 13c Other specify Hafnia sp. 29 alvei Capnocytophaga sp. 14 Other specify Helicobacter sp. 30a pylori Chlamydia sp. 15a pneumoniae 30b Other specify

15b trachomatis Haemophilus sp. 31a influenzae (beta-lactamase positive)

15c Other specify 31b influenzae (beta-lactamase negative)

Citrobacter sp. 16a freundii 31c parainfluenzae 16b koseri 31d Other specify 16c Other specify


APPENDIX 6 con’t MICROBIOLOGY ORGANISMS

Bacteria (con’t) Bacteria (con’t)

Klebsiella sp. 32a pneumonia Rickettsia sp. 51a ricketsii 32b oxytoca 51b Other specify 32c Other specify Salmonella sp. 52 Other specify Legionella sp. 33a pnemophillia Serratia sp. 53a liquefaciens 33b Other specify 53b marcescens Listeria sp. 34a monocytogenes 53c Other specify 34b Other specify Shigella sp. 54a dysenteriae Moraxella sp. 35a catarrhalis 54b Other specify

35b Other specify Staphylococcus sp. 55a Methicillin Resistant Staph Aureus (MRSA)

Morganella sp. 36a morganii 55b Methicillin Sensitive Staph Aureus (MSSA)

36b Other specify 55c aureus Mycoplasma sp. 37 Other specify 55d capitis Neisseria sp. 38a gonorrhoeae 55e Coagulase Negative 38b meningitidis 55f epidermadis 38c Other specify 55g haemolyticus Nocardia sp. 39a asteroides 55h hominis 39b Other specify 55i warneri Other Bacteria specify 40 Other specify 55j Other specify Pasteurella sp. 41a moltocida Stenotrophomas sp. 56a maltophillia 41b Other specify 56b Other specify Peptostreptococcus/ Pepto-coccus sp. 42a prevotti Streptococcus sp. 57a anginosus

42b Other specify 57b bovis or infantarius Porphyromonas sp. 43 Other specify 57c Group A (pyogenes) Prevotella sp. 44a melaningogenica 57d Group B (agalactiae) 44b Other specify 57e Group G (dysgalactiae) Propionibacterium sp. 45 Other specify 57f mutans Proteus sp. 46a mirabilis 57g pneumoniae 46b Other specify 57h viridans Providencia sp. 47a Other specify 57i Other specify Pseudomonas sp. 48a aeruginosa Streptobacillus sp. 58a moniliformis 48b fluorescens 58b Other specify 48c Other specify Vibrio sp 59a cholerae Ralstonia sp. 49 Other specify 59b Other specify Rhodococcus sp. 50a equi Yersinia sp. 60a enterocolitica 50b Other specify 60b pestis 60c Other specify


APPENDIX 6 con’t MICROBIOLOGY ORGANSIMS

Fungi/Yeast Virus Aspergillus sp. 61a flavus Adenovirus 70 61b fumigatus Cytomegalovirus 71 61c niger Hepatitis sp. 72a A 61d Other specify 72b B Bipolaris sp. 62 Other specify 72c C Blastomyces sp. 63 dermatitidis 72d Other specify Candida sp. 64a albicans Herpes sp. 73a Simplex 1 64b glabrata 73b Simplex 2 64c krusei HIV 74 64d parapsilosis Influenza 75a A 64e torulopsis 75b B 64f tropicalis Other Virus specify 76 Other specify 64g Other specify Coccidiomycosis sp. 65 Other specify Pneumocystis sp. 66 carinii or jirovecii Mycobacteria Rhodoturla sp. 67 mucilaginosa Avium-Intracellulare (MAI) 77 Not specified 68 Not specified Tuberculosis 78 Other Fungi/Yeast specify 69 Other specify Other Mycobacteria specify 79 Other specify


This document outlines the categories of infection that may be considered “outcomes” in a clinical trial. We have attempted to operationalize the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) and in doing so, have made modifications to those definitions. Furthermore, given the uncertainty around the diagnosis of infection, we have consistently used the terminology, ‘Definite’(a), ‘Probable’(b), and ‘Possible’(c) for each type of infection. The categories of infection are as follows: Category 1 Deep surgical wound infection Category 2 Incisional (or superficial) surgical wound infection Category 3 Skin and soft-tissue infection (non-surgical) (SSTS)

Category 4 Catheter-related blood stream infections (CRI) Category 5 Primary blood stream infections (BSI)

Category 6 Lower urinary tract infection Category 7 Upper urinary tract infection

Category 8 Intra abdominal infection Category 9 Sinusitis Category 10 Lower respiratory tract infection (excluding pneumonia) Category 11 ICU Acquired Pneumonia Category 12 Burn

Category 13 Other

APPENDIX 7

CATEGORIES OF INFECTION


Category 1 - Deep surgical wound infection

Deep surgical wound infection must meet the following criterion: Infection occurs at operative site within 30 days after surgery if no implant is left in place or within 1 year if implant is in place

AND

infection appears related to surgery

AND

infection involves tissues or spaces at or beneath fascial layer or a deeper anatomical space opened during the surgical procedure. In all categories, signs and symptoms suggestive of surgical site infection must be present. These include wound erythema and blanching, tenderness, pain, purulent discharge, fever, and leukocytosis.

a) Definite Infection

An abscess or other evidence of infection seen on direct examination, during surgery or by histopathologic examination.

OR

Organism isolated from culture of fluid obtained during open procedure or aspiration.

b) Probable Infection

Purulent drainage from drain placed beneath fascial layer (no microbial confirmation or Gram stain positive but negative culture).

c) Possible Infection

Wound spontaneously dehisces or is deliberately opened by surgeon (no pus or microbial confirmation).

APPENDIX 7-1



Category 2 - Incisional (or superficial) surgical wound infection

Incisional (or superficial) surgical wound infection must meet the following criterion: Infection occurs at incision site within 30 days after surgery

AND

involves skin and subcutaneous tissue above the fascial layer. In all categories, signs and symptoms suggestive of surgical site infection must be present. These include wound erythema and blanching, tenderness, pain, purulent discharge, fever, and leukocytosis.

a) Definite Infection

Organism(s) isolated from culture of fluid from wound closed primarily.


Purulent drainage from incision or drain located above fascial layer (no microbial confirmation or Gram stain positive but no positive culture).


Surgeon deliberately opens wound.

APPENDIX 7-2



Category 3 - Skin and soft tissue infection (non-surgical) Skin and soft tissue infection (non-surgical) or cellulitis must meet the following criterion: Infection occurs in skin or soft tissue structures (SSTS) NOT associated with surgical procedures.

a) Definite Infection Compelling clinical and laboratory evidence (such as spreading cutaneous erythema and blanching, or drainage or purulent material, with or without lymphangitis, in association with fever and leukocytosis) of the presence of SSTS infection based on clinical, radiographic, or surgical findings.

AND

Organism isolated from culture from a skin lesion that has drained pus or from a skin aspirate or biopsy of subcutaneous tissues of an erythematous skin lesion (not a simple skin swab).


Compelling clinical and laboratory evidence (such as spreading cutaneous erythema and blanching, or drainage or purulent material, with or without lymphangitis, in association with fever and leukocytosis) or the presence of SSTS infection based on clinical, radiographic, or surgical findings.

AND

No microbial confirmation or only positive Gram stain but negative culture.

c) Possible Infection Some clinical evidence of infection, such as mild cutaneous erythema associated with fever, some laboratory evidence (leukocytosis), some radiographic but insufficient evidence to confirm a diagnosis.

AND

No microbial confirmation.

APPENDIX 7-3



Category 4 - Catheter-related blood stream infections (CRI) Catheter-related blood stream infections (CRI) must be associated with an indwelling central line/arterial line (usually placed more than 5-7 days ago) and have an organism isolated from the bloodstream that is not related to infection as some other site (lungs, GI tract, etc.). In addition, patients must have signs of sepsis (fever, chills, hypotension, etc.):

a) Definite Catheter-related Infection

1. In association with a central line or arterial line, recognized pathogen (defined as a pathogen not usually

regarded as a skin contaminant) isolated from one or more blood culture.

AND

Catheter tip positive (>15 CFU/mL) or hub or exit site culture positive with the same organism.

OR

2. In association with a central line or arterial line, a common skin contaminant1 isolated from two or more blood cultures (at least one from a venipuncture).

AND

Catheter tip positive (>15 CFU/mL) or hub or exit site culture positive with the same organism.


1. In association with a central line or arterial line, recognized pathogen (defined as a pathogen not usually

regarded as a skin contaminant) isolated from one or more blood culture.

OR

2. In association with a central line or arterial line, a common skin contaminant isolated from two or more blood cultures (at least one from a venipuncture).


One of the following: fever (core temp >380C), chills, or hypotension in association with a central line or arterial line (with or without a positive catheter tip (>15 CFU/ml) or positive hub or exit site positive).2

AND

Patient’s clinical course improves with removal or change of the central line or arterial line and institution of appropriate antibiotic therapy.

1 Skin contaminants include diptheroids, Bacillus species, Propionibacterium, coagulase-negative Staphylococci, or micrococci) 2 A positive catheter tip culture (>15 CFU/mL) or positive exit site culture without systemic symptoms and improvement with removal or change of the central/arterial line and institution of appropriate antibiotic therapy is not considered to be indicative of a central/arterial line infection.

APPENDIX 7-4



Category 5 - Primary blood stream infections (BSI) Primary blood stream infections (BSI) must NOT be associated with a indwelling vascular device or related to infection as some other site (lungs, GI tract, etc.). In addition, patients must have signs of sepsis (fever, chills, hypotension, etc.):

a) Definite Blood Stream Infection

1. A recognized pathogen (defined as a pathogen not usually regarded as a skin contaminant) isolated from one or

more blood culture.

OR

2. A common skin contaminant isolated from two or more blood cultures drawn on separate occasions (from venipunctures; must not be associated with a indwelling vascular device).

{there is no definition of ‘probably infection’ for this category}

b) Possible Infection

A common skin contaminant isolated from a blood culture that does not fulfill the definition of ‘Definite” BSI.

AND

Patients clinical course improves with institution of appropriate antibiotic therapy.

APPENDIX 7-5



Category 6 - Lower urinary tract infection (LUTI)

a) Definite

Symptoms (fever - core temp > 38oC), hypotension) and Pyuria (>10 white blood cells {WBC}/ml

AND

a positive urine culture of >105 colonies/ml urine with no more than two species of organisms.

AND

No other sources of the patient’s signs and symptoms are identified.

b) Probable

Symptoms (fever - core temp > 38oC), hypotension).

AND

A urine culture of >105 colonies/ml urine with no more than two species of organisms.

c) Possible*

A urine culture of >105 colonies/ml urine with no more than two species of organisms.

* Candida isolated in the urine may be considered indicative of a possible UTI if the attending physician feels that it is significant and institutes management for it (either/both changes the catheter or institutes antifungal therapy)

APPENDIX 7-6



Category 7 - Upper Urinary Tract Infection

Upper Urinary Tract Infection includes infections of the urinary tract (kidney, ureter, bladder, urethra, or perinephric spaces).

a) Definite:

Organism isolated from culture of fluid (other than urine) or tissue from affected site.

OR

An abscess or other evidence of infection seen on direct examination, during surgery, or by histopathologic examination.

b) Probable Two of the following: fever (core temp >380C), urgency, localized pain, or tenderness at involved site

AND any of the following:

Purulent drainage from affected site.

Positive Gram stain from fluid from affected site.

Organism isolated from urine or blood culture.

Radiographic evidence of infection.

c) Possible Two of the following: fever (core temp >380C), localized pain, or tenderness at involved site

AND any of the following:

Physician’s diagnosis.

Physician institutes appropriate antimicrobial therapy and patient responds appropriately.

APPENDIX 7-7



Category 8 - Intra abdominal infection

Intra abdominal infection includes gallbladder, bile ducts, liver [other than viral hepatitis], spleen, pancreas, peritoneum, subphrenic or subdiaphragmatic space, pelvis or other intra abdominal tissue or area not specified elsewhere, and must meet the following criteria:

a) Definite

1. Organism(s) isolated from culture of purulent material from intra abdominal space/structure obtained during surgery or needle aspiration.

OR

2. Abscess or other evidence of intra abdominal infection (such as soilage of the peritoneal cavity after intestinal perforation) seen during surgery or by histopathologic examination.

OR

3. Pseudomembranous colitis- Direct visualization of pseudomembranes during sigmoidoscopy or on examination of surgically removed specimens of the colon.

b) Probable

1. In the appropriate clinical setting, organism isolated from blood culture and:

Radiographic evidence for intra-abdominal infection.

OR

Clinical evidence of intra-abdominal infection (Abdominal Pain, Systemic leukocytosis, tenderness, jaundice).

OR

Laboratory evidence of intra-abdominal infection (inflammatory ascitic fluid i.e. > 500 PMN/ml, evidence of billiary obstruction, positive gram stain of fluid from abdominal cavity but negative cultures).

2. Organisms seen on Gram stain of drainage or tissue obtained during surgery or needle aspiration but cultures are negative.

3. Pseudomembranous colitis- Toxin isolated from the stool in the setting of clinical illness compatible with Pseudomembranous colitis (exposure to antibiotics, diarrhea, colonic dilation, toxic megacolon, etc.).

c) Possible: one of the following:

1. Upper Gastro-intestinal perforation or penetrating abdominal trauma that is surgically repaired without further evidence of microbiologic confirmation or clinical signs or symptoms supportive of a diagnosis of bacterial or fungal peritonitis.

2. Clinical evidence of intra-abdominal infection with an inflammatory peritoneal fluid (> 500 leucocytes/ml for primary peritonitis and >100 leukocytes/ml for peritoneal dialysis related peritonitis) in the absence of a positive culture (in peritoneal fluid or blood) or gram stain.

3. Organism isolated from culture of drainage from surgically placed drain (e.g., closed suction drainage system, open drain or T-tube drain).

4. Clinical evidence of intra-abdominal infection with persistent signs of systemic inflammation but without clear documented evidence of persistent inflammation within the peritoneal space following secondary bacterial peritonitis.

5. Clinical evidence of intra-abdominal infection with signs of systemic inflammation which improves with the institution of systemic antibiotics (e.g. cholecystitis treated with antibiotics only).

6. Pseudomembranous colitis- Pseudomembranous colitis suspected on clinical grounds but toxin not sent or negative, colonoscopy not done and therapy instituted.

APPENDIX 7-8



Category 9 - Sinusitis

a) Definite Organism isolated from culture of purulent material directly obtained from sinus cavity by antral puncture. b) Probable One of the following: fever (core temp >380C), pain or tenderness over the involved sinus, headache, purulent exudate, or nasal obstruction.

AND

Radiographic evidence of infection. c) Possible Two of the following: fever (core temp >380C) or pain or tenderness over the involved sinus, headache.

AND

purulent nasal exudate.

APPENDIX 7-9



Category 10 - Lower respiratory tract infection (excluding pneumonia)

Lower respiratory tract infection (excluding pneumonia) includes infections such as bronchitis, tracheobronchitis, bronchiolitis, tracheitis, lung abscess, and empyema.

a) Definite:

Organism seen on smear or isolated from culture of lung tissue or fluid, including pleural fluid.

b) Probable: 1. Lung abscess or empyema seen during surgery or by histopathologic examination but no microbiological

confirmation.

2. For bronchitis, tracheobronchitis, bronchiolitis, tracheitis, without evidence of pneumonia, must meet the following criterion:

Patient has no clinical or radiographic evidence of pneumonia but has fever (core temp >38 C) and increased sputum production.

AND

Organism isolated from culture obtained by deep tracheal aspirate or bronchoscopy.

c) Possible Abscess cavity seen on radiographic examination of lung.

APPENDIX 7-10



Category 11 - ICU-Acquired Pneumonia

ICU-Acquired Pneumonia includes HAP and VAP. It must be associated with a clinical suspicion of pneumonia defined as new, progressive, or persistent infiltrates on CXR and be associated with signs and symptoms of infection (fever, leukocytosis, worsening oxygenation, purulent secretions, etc.).

a) Definite Pneumonia Radiographic evidence of pulmonary abscess and positive needle aspirate.

OR

Histological proof on open lung biopsy or at post mortem (abscess formation, or consolidation with PMN accumulation).

b) Probable Pneumonia Must be associated with a positive culture of a pathogen known to cause pneumonia. For example, positive cultures for Coagulase Negative Staph. Species or normal oral flora would not be considered as positive since they do not usually cause VAP/HAP. The positive cultures need to come from 1 of the following:

A sputum or an endotracheal aspirate specimen.

A culture of bronchial washings, BAL or PSB regardless of quantitation (if done).

A blood culture of an organism found within 48 hours of the clinical suspicion of VAP/HAP.

A positive pleural fluid culture.

c) Possible Pneumonia No microbial confirmation in the setting of a clinical suspicion for pneumonia as described above, and a clinical course compatible with VAP/HAP including the institution of appropriate antimicrobial therapy.

APPENDIX 7-11



Category 12 - Burn

Burn wound infection must meet the following criterion (based on ABA Consensus Conference): Infection occurs at the burn operative site and appears to be related to surgery. In all categories, signs and symptoms suggestive of surgical site infection must be present. These include wound erythema and blanching, tenderness, pain, purulent discharge, fever, and leukocytosis.

a) Definite

Definite burn wound infection is a quantitative culture of living tissue under burn eschar containing >105 pathogens/gram. Additionally, a quantitative culture containing pathogens at less than 105 organisms per gram in association with cellulitis in adjacent skin can be considered ‘Definite’ .

*For a definite wound infection, quantitative cultures of the living tissue beneath the eschar must be done (not quantitative cultures of the dead tissue/eschar). Positive swabs are not acceptable for a diagnosis of definitive wound infection .

b) Probable

Probable burn wound infection is early separation of eschar or other characteristic changes in the eschar, or graft-loss, with surrounding cellulitis and/or systemic signs of infection, without confirmation by quantitative culture

c) Possible

Possible burn wound infection could also include a patient with systemic signs of infection and a large burden of eschar, but no other probable or proven source (lungs, lines, urine). Please note if the only presenting signs and symptoms pertain to cellulitis, there is a separate categorization for Skin and soft tissue infection (see category 3). Comments: ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________

APPENDIX 7-12



Category 13 - Other

If the patient developed an infection which does not fall into any of the previous categories. Please describe below.

a) Definite

Clinical evidence of infection and one of the following:

The culture of an organism(s) or positive Gram stain or positive viral cultures from a normally sterile bodily fluid or tissue in the absence of previous surgical intervention (e.g. organism isolated from CSF or synovial fluid).

OR

Positive antigen/RNA/DNA test for pathogens from a normally sterile bodily fluid.

OR

Positive viral/bacterial serology.

b) Probable

Clinical evidence of infection and of one the following:

The culture of a pathogenic organism(s) or positive Gram stain positive or positive viral culture from a body site that is not normally sterile or a specimen obtained from an indwelling drain or catheter placed into a normally sterile body site (e.g. intra-abd. drain).

OR

Positive antigen/RNA/DNA test for pathogens from a body site that is not normally sterile.

c) Possible Clinical evidence of infection but no microbiologic, smear or serological confirmation of infection.

Please describe infection: ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________

APPENDIX 7-13



APPENDIX 8

DEFINITION OF “NO” NEWLY ACQUIRED INFECTION

If “No” to infection, choose either one, Probable No or Possible No Probable No With greater certainty, the Investigator feels the patient is NOT infected. Clinical story is clearly consistent with no infection supported by lack of physiologic response (SIRS), or no positive cultures, or no treatment with anti-biotics (short-term prophylaxis OK), and patient gets better. Examples:

Patient with ischemic heart disease (IHD) admitted to ICU in cardiogenic shock. No positive cultures, no treatment with antibiotics, and patient gets better. Even if the patient dies, if there is no suggestion of infection or no treatment with antibiotics, the patient could still be “probably not infected”. Patient with multiple traumas admitted to ICU on ventilator. Has SIRS for 24-48 hours (probably related to trauma), no organ dysfunction, no positive cultures, only short-term antibiotic prophylaxis, and gets better in a few days. Clear cut cases related to “colonization” or “contamination” should be categorized here (i.e., cultures that are positive secondary to organisms likely to reflect contamination or colonization that get better with no treatment).

Possible No Investigator believes the patient is not infected but with some degree of uncertainty. Investigator cannot comfortably rule out infection but thinks it is not likely. Patient may manifest SIRS and organ dysfunction secondary to some other process but was treated with antibiotics. Examples:

Patient admitted to ICU with severe necrotizing pancreatitis. Patient had SIRS and MODS and is treated with antibiotics from the beginning despite the lack of positive cultures. (prophylaxis for secondary pancreatitic complications). Patient with ischemic heart disease admitted to ICU in cardiogenic shock. CXR shows a bilateral process compatible with pulmonary edema. Patient receives treatment of IHD and cardiogenic shock and seems to improve. On Study Day 1 while in ICU, patient spikes a fever and is started on antibiotics.

case report forms (crfs) - critical care nutrition · example: t-bilirubin was ... study day 1 =...

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