7. Re-measure lactate if initial lactate elevated

Only if septic shock is present:

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

Recognition**

Recognition**

Recognition**

3-Hour Bundle**

6-Hour Bundle** Table 1**

Noninvasive ClearSight Finger Cu�

The noninvasive ClearSight finger cu� o�ers access to advanced hemodynamic parameters that provide valuable hemodynamic insight to help guide your detection of fluid responsiveness and make more informed volume administration decisions.1–3

PreSep OximetryCatheter

PreSep catheter is a proactive tool to help you stay ahead of septic shock.4–8

Minimally-InvasiveFloTrac Sensor

FloTrac Sensor connects to any a-line, to escalate the level of monitoring as patient acuity changes.

WBC > 12,000/mm>3, < 4,000/mm>3, or > 10% bands

Respiratory Rate >20

Heart Rate >90

Temp >38.3°C (100.9°F) OR <36°C (96.8°F)

≥2 symptoms of SIRS

Dynamic assessment of fluid responsiveness with passive leg raise or fluid challenge

Bedside cardiovascular ultrasound

Measure ScvO2

Measure CVP

OR two of the following:

Capillary Refill

Cardiopulmonary

and Skin Findings

Pulse

Vital Signs

EITHER repeat focused exam after initial fluid resuscitation by licensed independent practitioner (performed and documented by physician/APN/PA) including:

Platelet count <100,000

INR > 1.5 or aPTT >60 sec.

Acute respiratory failure as evidenced by need for invasive or noninvasive mechanical ventilation

OR Lactate > 2 mmol/L (18.0 mg/dL)

Bilirubin >2 mg/dL (34.2 mmol/L)

Creatinine >2.0, OR urine output <0.5 mL/kg/hour for 2 hours

Systolic blood pressure <90, OR mean arterial pressure <65, OR a systolic blood pressure decrease of more than 40 points

Organ dysfunction (any one of the followingthat is NOT due to a chronic condition or medication induced)

OR a systolic blood pressure decrease of more than 40 points

OR mean arterial pressure <65,

Systolic blood pressure <90,

Tissue hypoperfusion in the hour following crystalloid fluid administration, evidenced by 2 or more consecutive BP readings of either:

Document reassessment of volume status and tissue perfusion with:

3. Administer broad spectrum antibiotics

2. Obtain blood cultures prior to the administration of antibiotics

1. Measure lactate level

To be completed within 3 hours of the time of presentation*

If lactate > 2, repeat within 6 hours of time of presentation*

Sepsis criteria

Documentation of a known or

suspected source of clinical

infection +

Severe sepsis

criteriaSepsis +

Septic shock

criteriaSevere sepsis +

6. In the event of persistent hypotension after initial fluid administration (MAP <65 mmHg) OR if initial lactate was > -4 mmol/L, reassess volume status and tissue perfusion and document findings according to Table 1

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

To be completed within 6 hours of the time of presentation*

ClearSight Finger Cu�& FloTrac Sensor

Edwards’ ClearSight finger cu� and/or FloTrac Sensor can be used to measure flow-based parameters continuously prior to, during, and after the fluid administration portion of the 3-hour bundle.

OR Lactate level ≥ 4 mmol/L YES

YES

CMS required reporting begins with the 3-hour bundle

Sepsis bundle guidelinesEdwards Lifesciences’ monitoring solutions provide dynamic and flow-basedparameters to aid in the early detection of sepsis, guide treatment, and complywith NQF/CMS bundle requirements.

** Centers for Medicare and Medicaid Services: Sepsis Bundle Project (SEP); Specifications Manual for National Hospital Inpatient Quality Measures Discharges 10-01-15 (4Q15) through 06-30-16 (2Q16). Published March 30, 2015.

The Sepsis Bundle Guidelines as presented above were published by CMS on March 30, 2015 and are presented for informational purposes only. This information does not constitute reimbursement or medical advice. Edwards makes no representation or warranty regarding this information or its completeness, accuracy or timeliness. It is not intended to make a recommendation regarding clinical practice. Laws, regulations, and payer policies concerning reimbursement are complex and change frequently; service providers are responsible for all decisions relating to clinical services, coding and reimbursement submissions. Accordingly, Edwards strongly recommends consultation with CMS, payers, reimbursement specialists and/or legal counsel regarding guidelines, coding, coverage, and reimbursement matters.

* Time of presentation is the time of the earliest chart annotation consistent with all elements of severe sepsis or septic shock ascertained through chart review.

† Data on file.

1. Bubenek S, Craciun M, Miclea I, Perel A. Noninvasive continuous cardiac output by the Nexfin before and after preload-modifying maneuvers: a comparison with intermittent thermodilution cardiac output. Anesthesia & Analgesia 2013; 117(2):366-72.

2. Maguire S, Rinehart J, Vakharia S, Cannesson M. Respiratory variation in pulse pressure and plethysmographic waveforms: Intraoperative applicability in a north American academic center. Anesthesia & Analgesia 2011; 112: 94-96

3. Martina J. Noninvasive continuous arterial blood pressure monitoring with NexFin. Anesthesiology 2012; 116: 1-12.4. Reinhart K, et al. Continuous central venous and pulmonary artery oxygen saturation monitoring in the critically ill. Intensive Care

Med. 2004;30(8):1572-8. 5. Rivers EP, et al. Central venous oxygen saturation monitoring in the critically ill patient. Curr Opin Crit Care. 2001;7(3):204-11. 6. Ingelmo P, et al. Importance of monitoring in high risk surgical patients. Minerva Anestesiol. 2002;68(4):226-30. 7. Scalea TM, et al. Central venous oxygen saturation: a useful clinical tool in trauma patients. J Trauma. 1990;30(12):1539-43.8. Ander DS, et al. Undetected cardiogenic shock in patients with congestive heart failure presenting to the emergency department.

Am J Cardiol. 1998;82(7):888-91.

For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, ClearSight, FloTrac, and PreSep are trademarks of Edwards Lifesciences Corporation or its a�liates. All other trademarks are the property of their respective owners.

© 2016 Edwards Lifesciences Corporation. All rights reserved. PP--US-0803 v1.0

Edwards Lifesciences • One Edwards Way, Irvine CA 92614 USA • edwards.com

Know more. Know now.For educational tools and resources, visit edwards.com/ecce

Parameters SVV | SV | CCO

Parameters ScvO2

| CVP

PreSep Oximetry Catheter

FloTrac Sensor

Parameters SV | SVV | SVR | CO | cBP

ClearSightFinger Cu�

The noninvasive ClearSight finger cu� o�ers access to dynamic and flow-based parameters parameters that provide valuable insight to help guide treatment evaluation.1–3 The simplicity of the ClearSight finger cu� extends the benefits of hemodynamic monitoring for a broader patient population.

The FloTrac Sensor has been chosen by clinicians more than any other minimally-invasive volume management solution to monitor over 2.5 million patients worldwide.† The FloTrac system easily connects to any existing arterial catheter and automatically calculates key flow parameters every 20 seconds, making it the practical and reliable solution for hemodynamic optimization in moderate to high-risk surgery.

A proactive tool to help you stay ahead of shock, the PreSep Oximetry Catheter provides continuous ScvO2, a global measure of oxygenation. This may help you detect critical changes earlier than vital signs alone – enabling you to respond to these changes sooner.4 –8