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IHI ExpeditionTreating Sepsis in the Emergency Department and

Beyond Session 3

Thursday, October 10, 2013

These presenters have nothing to disclose

Sean Townsend, MD

Diane Jacobsen, MPH, CPHQ

Today’s Host2

Max Cryns, Project Assistant, Institute for Healthcare Improvement (IHI), assists programming activities for hospital settings including Expeditions (2-4 month web-based educational programs), Passport memberships, and mentor hospital relations. He also supports IHI’s networking and knowledge efforts. Max is currently in the Co-Operative Education Program at Northeastern University in Boston, MA, where he majors in Business Administration with concentrations in Entrepreneurship and Marketing. He enjoys professional and collegiate sports, playing basketball, music, the beach, and trivia.

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Expedition Director5

Diane Jacobsen, MPH, CPHQ, Director, Institute for Healthcare Improvement (IHI) is currently directing the CDC/IHI Antibiotic Stewardship Initiative, NSLIJ/IHI Reducing Sepsis Mortality Collaborative. Ms Jacobsen served as IHI content lead and improvement advisor for the California Healthcare-Associated Infection Prevention Initiative (CHAIPI) and directed Expeditions on Antibiotic Stewardship, Preventing CA-UTIs, Reducing C. difficile

Infections, Sepsis, Stroke Care and Patient Flow. She served as faculty for IHI’s 100,000 Lives and 5 Million Lives Campaign and directed improvement collaboratives on Sepsis Mortality, Patient Flow, Surgical Complications, Reducing Hospital Mortality Rates (HSMR) and co-directed IHI's Spread Initiative She is an epidemiologist with experience in quality improvement, risk management, and infection control in specialty, academic, and community hospitals. A graduate of the University of Wisconsin, she earned her master's degree in Public Health-Epidemiology. from the University of Minnesota.

Today’s Agenda6

Introductions

Debrief: Action Period Assignment

Lactate and Blood Culture Collection: Getting to Results within One Hour

Action Period Assignment

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Expedition Objectives

By the end of the Expedition participants will be able to:

Describe the latest evidence based care for patients with severe sepsis and septic shock

Design reliable processes to ensure that each patient receives all elements of the best possible care at each opportunity

Identify key opportunities and test changes on medical/surgical units to improve early recognition of sepsis in a care context which has been challenging for providers

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Schedule of CallsSession 1 – Clinical Updates to the Surviving Sepsis Campaign Guidelines: The 3 Hour Resuscitation BundleDate: Thursday, September 12, 1:00-2:30 PM ET

Session 2 – Key Considerations for Enhancing Reliability with Antibiotic Therapy in the Emergency Department and in Inpatient FloorDate: Thursday, September 26, 1:00-2:00 PM ET

Session 3 – Lactate and Blood Culture Collection: Getting to Results Within One HourDate: Thursday, October 10, 1:00-2:00 PM ET

Session 4 – Ensuring Reliable Care from the Patient PerspectiveDate: Thursday, October 24, 1:00-2:00 PM ET

Session 5 – Early Recognition and Monitoring of the Sepsis Patient on the Inpatient FloorDate: Thursday, November 7, 1:00-2:00 PM ET

Session 6 – Considerations and Challenges with Fluid ResuscitationDate: Thursday, November 21, 1:00-2:00 PM ET

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Faculty9

Sean R. Townsend, MD, Vice President of Quality and Safety, California Pacific Medical Center (CPMC), is also a practicing intensivist in the Division of Pulmonary and Critical Care at CPMC. Previously, he was Assistant Professor of Medicine at the University of Massachusetts and at Brown University Medical School. Dr. Townsend has been faculty advisor to IHI's 100,000 Lives and 5 Million Lives Campaigns for the ventilator-associated pneumonia and catheter-related bloodstream infections interventions. He led IHI's work on sepsis as part of the Improving Outcomes for High-Risk and Critically Ill Patients Learning and Innovation Community, and he is current faculty for the Reducing Sepsis Mortality Collaborative. A member of the Surviving Sepsis Campaign (SSC) executive committee, he is an author of the 2008 SSC International Guidelines on the Management of Severe Sepsis and Septic Shock and 2010 SSC Results of an International Guideline-based Performance Improvement Program Targeting Severe Sepsis.

Debrief: Action Period Assignment

For the Emergency Department:

Develop a high level process map for 2-3 patients identified with sepsis in the ED to identify delays or constraints from time of antibiotic selection to delivery(e.g., timing, communication, availability of antibiotic, etc.)

Complete a PDSA based on the delay or constraint identified:

– Complete a PDSA of using a visual clock at bedside with time for antibiotic to be administered

– Focus in ED – complete a PDSA to make commonly used antibiotics immediately available in the ED

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Action Period Assignment

For the inpatient floor:

Develop a high level process map for 2-3 patients identified with sepsis on the inpatient floor to identify delays or constraints from antibiotic selection to delivery(e.g., timing, communication, availability of antibiotic, etc.)

Complete a PDSA based on the delay or constraint identified:

– Complete a PDSA of using a visual clock at bedside with time for antibiotic to be administered

– Complete a PDSA on one unit by placing key antibiotics in electronic dispensing (i.e., Pyxis) to decrease the time to antibiotic administration

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Change Ideas

Antibiotic protocols for common conditions

“Code sepsis” team

Store common antibiotics on the unit

Sepsis Dashboard

– Time to antibiotics

– Percent severe sepsis/septic shock patients receiving antibiotics within 1 and 3 hours

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Lactate & Blood Culture Collection

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Session Objectives

Discuss the relationship between lactate compliance, category and hypotension and hospital mortality.

Identify barriers to ensuring lactates and blood cultures are reliably collected and results reported within one hour.

Review potential solutions to expedite timely lactate and blood cultures prior to antibiotics.

Identify 1-2 specific ideas to test in their hospital for enhancing antibiotic timing and selection.

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NQF BUNDLE: Sepsis 0500

TO BE COMPLETED WITHIN 3 HOURS OF TIME OF PRESENTATION†:

1. Measure lactate level

2. Obtain blood cultures prior to administration of antibiotics

3. Administer broad spectrum antibiotics

4. Administer 30ml/kg crystalloid for hypotension or lactate ≥4mmol/L

† “time of presentation” is defined as the time of triage in the Emergency Department or, if presenting from another care venue, from the earliest chart annotation consistent with all elements severe sepsis or septic shock ascertained through chart review.

NQF BUNDLE: Sepsis 0500

TO BE COMPLETED WITHIN 6 HOURS OF TIME OF PRESENTATION:

5. Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure (MAP) ≥65mmHg)

6. In the event of persistent arterial hypotension despite volume resuscitation (septic shock) or initial lactate ≥4 mmol/L (36mg/dl):

– Measure central venous pressure (CVP) – Measure central venous oxygen saturation (ScvO2)*

7. Remeasure lactate*

* Targets for quantitative resuscitation included in the guidelines are CVP of ≥8 mm Hg, ScvO2 of ≥70% and lactate normalization.

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Hospital Mortality by Lactate Compliance, Lactate Category, and Hypotension

Lactate group

Lactate measured ≤ 6 hours Lactate measured > 6 hours

No hypotension Hypotension No hypotension Hypotension

N Mortality N Mortality N Mortality N Mortality

≤ 2.0 1,290 23.2 5,098 27.7 366 29.5 1,395 29.7

> 2.0 to ≤ 3.0 992 23.9 3,200 30.8 142 31.7 612 36.1

> 3.0 to ≤ 4.0 677 22.7 2,245 31.7 72 37.5 355 42.3

> 4.0 966 29.4 5,195 44.6 106 50.9 716 58.7

Total 3,925 24.8 15,738 34.5 686 34.1 3,078 39.2

Mortality Odds Ratios by Lactate Compliance, Category, and Hypotension

Lactate group

Lactate measured ≤ 6 hours Lactate measured > 6 hours

No hypotension Hypotension No hypotension Hypotension

OR, 95% CI

p-value

OR, 95% CI

p-value

OR, 95% CI

p-value

OR, 95% CI

p-value

1. ≤ 2.0

(referent)--- --- --- ---

1. > 2.0 to ≤ 3.01.03, 0.86 – 1.24

0.736

1.16, 1.06-1.28

0.002

1.17, 0.92-1.49,

0.128

1.32, 1.10-1.59

0.003

1. > 3.0 to ≤ 4.00.98, 0.80-1.20

0.846

1.21, 1.09-1.35

< 0.001

1.41, 1.06-1.87

0.020

1.74, 1.39-2.17

< 0.001

1. > 4.01.40, 1.17-1.67

< 0.001

2.10, 1.94-2.28

< 0.001

2.27, 1.80-2.87

< 0.001

3.41, 2.86-4.06

< 0.001

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EGDT Protocol: ScvO2 v lactate clearance

Currently several observational studies and one RCT using EGDT bundle including ScvO2 show improved mortality

ScvO2 has been included in sepsis guideline management and Institute of Healthcare Improvement recommendations

Recently two multi-center RCT have evaluated using lactate clearance either in lieu of or in conjunction with ScvO2

So where are we now?

Neck or chest central catheter

Septic patients +

hypotension or hypoperfusion

CVP > 8 mm Hg CVP > 8 mm Hg

MAP > 65 mm Hg MAP > 65 mm Hg

ScvO2 > 70% Lactate clearance > 10%

JAMA 2010;303(8):739

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ScvO2 Arm

ScvO2 > 70%If Hct < 30%

transfuse PRBC

If Hct. > 30%administer dobutamine

No

Recheck

Lactate Clearance Arm

• Lactate initial: measured at resuscitation initiation• Lactate delayed: 2nd measurement after minimum 2 hours• Goal met if: • Kactate clearance of at least 10%

Lactate clearance > 10%If Hct < 30%

transfuse PRBC

If Hct. > 30%administer dobutamine

No

Recheck 1hr minimum

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JAMA 2010;303(8):739

Neck or chest central line

Septic patients +

hypotension or hypoperfusion

CVP > 8 mm Hg4.3 L

CVP > 8 mm Hg4.5 L

MAP > 65 mm Hgn = 113 (75%)

MAP > 65 mm Hgn = 108 (72%)

ScvO2 > 70%n = 13

Lactate clearance > 10%n = 16

Vasopressor administrationn = 221 (74%)

IVF administration

Dobuatamine / PRBCtotal n = 29 (10%)

-----------------------------------------------------------------------------

Compared intervention

n = number receivingintervention

Power to Answer the Question?

Noninferiority implies not worse than...

In this study: Power analysis to determine that noninferiority was not due to chance alone (assuming 25% mortality, alpha = 0.05)

– Required 150 patients administered one of the two treatments being compared:

– 300 patients total should receive treatment via ScvO2 or lactate clearance

– 71% power to determine if lactate clearance did not increase mortality by more than 10%

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Power to Answer the Question?

Power analysis = 300 patients requiring one of the two interventions being tested

Only 10% of patients (n=29) got to the point in the protocol that required one of the two interventions being compared – ScvO2 normalization v lactate clearance

To recruit 300 patients requiring interventions to optimize ScvO2 or lactate clearance would have required 3,000 patients

Is 10% Lactate Clearance Sufficient?

JAMA study: 10% lactate clearance = success

Clearance does not equal lactate normalization

Adequate % reduction depends on initial lactate

Patient presents with a lactate of 10 mmol/L

– 10% clearance = 1 mmol/L difference

– Resulting lactate goal = 9 mmol/L

– Although 10% lactate clearance achieved, still inadequate

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ICU patients admitted with a lactate level > 3 mEq/L

– Randomized to either control or lactate clearance

Patients have same initial theraputic end-points

– MAP > 60 mm Hg

– CVP 8 - 12 mm Hg

– Urine Output > 0.5ml/kg/hr

– SaO2 > 92%

To achieve end-points, ScvO2 guided management allowed in both groups

– Mandatory in lactate

clearance group

– Optional in control (non-

lactate clearance)

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If lactate elevated in treatment group:

Protocol administered using ScvO2 early to guide management

Therapeutic endpoints:

– Same hemodynamic goals as control combined with

– 20% lactate reduction every 2 hours until lactate < 2 mEq/L

Reduced adjusted in-hospital mortality

Reduced adjusted ICU mortality

Was not maintained at 28 days

✤ With encouraging results:

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immediately before the start of the study. However, given that Scvo2 monitoring was mandatory in the lactate group and facultative in the control group, we cannot exclude the possi-bility that this had an impact on the observed outcome difference. Third, an important limitation of the study design is

Author assessment:

compared to the control group. Our study therefore confirms the early goal-directed therapy results (19), underscoring the importance of adequate resuscitation as long as lactate levels remain elevated, even after ICU admission after early stabilization in the emergency department. In addition, our study extends the concept of early goal-directed therapy to other patient groups, as only about 40% of the patients enrolled in the current study had sever sepsis or septic shock.

Author assessment:

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Author assessment

Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61.

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Blood Culture Collection

To optimize identification of causative organisms, we recommend at least two blood cultures be obtained before antimicrobial therapy is administered as long as such cultures do not cause significant delay (>45 minutes) in antimicrobial administration, with at least one drawn percutaneously and one drawn through each vascular access device, unless the device was recently (<48 hr.) inserted (Grade 1C).

Importance of Early Antibiotics

We recommend that intravenous antimicrobial therapy be started as early as possible and within the first hour of recognition of septic shock (1B) and severe sepsis without septic shock (grade1C).

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What is a blood culture ?

A microbiological culture of the blood to detect infection with a micro organism, specifically bacteria or candida.

The blood is usually a sterile substance.

If an organism grows - more tests will identify type and antibiotic sensitivity

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Contamination

Growth of organisms in the blood culture bottle that were not present in the patient’s blood stream

Introduced during sample collection from:– Patients skin,

– Equipment used to take sample and transfer it to bottle

– Hands of the person taking sample

Contamination rates– Estimated that at present 10% of all blood cultures in Scotland are

contaminated.

– Aiming for an in patient rate of <3%.

Contamination of Samples has Important Consequences

1. Patient – Unnecessary investigations

– Errors in clinical interpretation

– Administration of inappropriate treatment

2. Inappropriate use of antibiotics – Potentiates emergence of multi-resistant organisms

– Increases risk of Clostridium difficile infection

3. Cost to the hospital & insurers– Average length of stay increased by 4.5 days

– Average overall cost of treatment increased by $15K.

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4. Surveillance

– Decreases accuracy of surveillance data on septicemia

5. Performance management

– Negatively affects performance

– management targets around patient

– safety

Contamination of Samples has Important Consequences

Indications for Blood Cultures

Presence of 2 or more of SIRS (Systemic Inflammatory Response Syndrome) criteria:

Core Temperature <36 or>38Respiratory Rate >20 per minWCC >12 or <4 x109Pulse >90bpmAltered mental stateBM> 8mmol (if not a diabetic)

Even if only one of these criteria is present there may be clinical indications to take a Blood Culture sample

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When to take Blood Cultures?

When

After indications met

Before administration of antibiotics or a change of antibiotics

If patient is on antibiotics, blood cultures should be taken immediately before next dose (with exception of paediatric patients).

How many sets of cultures?

Obtaining more than one set of cultures :– Significantly increase the sensitivity of the test

– Assists with determining whether a sample is contaminated

Source control

We recommend that a specific anatomical diagnosis of infection requiring consideration for emergent source control (e.g., necrotizing soft tissue infection, peritonitis complicated with intra-abdominal infection, cholangitis, intestinal infarction) be sought and diagnosed or excluded as rapidly as possible, and if needed, surgical drainage should be undertaken for source control within the first 12 hr after the diagnosis is made. (Grade 1C).

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Questions?45

Raise your hand

Use the Chat

Action Period Assignment

Complete a PDSA to expedite lactate and blood culture collection:– Pre-bundle blood culture bottles and lactate tube with sepsis sticker label

– Partner with laboratory to expedite collection & transport of specimens

– Other PDSA based on your current process

Complete a PDSA to expedite lactate reporting:– Alert lab to priority order for lactate (i.e., send a card/prompt identifying

“code sepsis” with lab specimen)

– Partner with laboratory to expedite results reporting to ED or inpatient unit via phone, text, etc.

– Other PDSA based on your current process

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Expedition Communications

Listserv for session communications: TreatingSepsis@ls.ihi.org

To add colleagues, email us at info@ihi.org

Pose questions, share resources, discuss barriers or successes

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Next Session

Thursday, October 24, 1:00-2:00 PM ET

Session 4 - Ensuring Reliable Care from the Patient Perspective

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