SEPSIS UPDATE WHY DO WE NEED A CORE MEASURE CHAD M. KOVALA DO, FACOEP, FACEP
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1 SEPSIS UPDATE WHY DO WE NEED A CORE MEASURE CHAD M. KOVALA DO, FACOEP, FACEP
2 OBJECTIVES Arise, ProMISE, ProCESS Key points in sepsis management The CMS sepsis core measure
3 COST OF SEPSIS CARE IN US Most expensive condition to treat in the US since 2008 Hospital cost in 2011 > $20 Billion Hospital cost in 1997 $4.4 Billion Likely underestimated
4 RIVERS AND EGDT FOR SEVERE SEPSIS AND SEPTIC SHOCK 263: EGDT vs Standard Enrollment: 2 SIRS plus 1. Lactace 4 2. SBP < 90 after ml/kg bolus Mortality 30.5% EGDT Mortality 46.5% Standard
5 PROCESS 2014 All groups ~ 2200 ml bolus before enrollment Antibiotics within ~ 100 minutes Eligibility: 2 SIRS + either 1. Refractory hypotension (after bolus) SBP < 90 or vasopressors OR 2. Lactate 4
6 ARISE 2014 Similar enrollment criteria to ProCESS Eligibility: 2 SIRS + either 1. Refractory hypotension (after bolus) SBP < 90 or MAP < 65 OR 2. Lactate 4
7 ARISE AND PROCESS BIG PICTURE 1. All patients received aggressive IVF before enrollment ( ml) 2. Most patients received antibiotics within 100 minutes
8 KEY STATEMENT FROM ARISE The results of our trial show that EGDT, as compared with usual resuscitation practice, did not decrease mortality among patients presenting to the emergency department with early septic shock.
9 WHERE DO WE STAND NOW? What fundamentals of sepsis care remain if a protocol is not necessary?
10 KEY POINT #1 TIMING OF ANTIBIOTICS Mortality increases every hour that antibiotics are not given within the 1 st six hours of evaluation. Kumar et al. Crit Care Med 2006 Gaieski et al. Crit Care Med 2010 Farrer et al. Crit Care Med 2014
11 KEY POINT #2 CHOOSE THE ANTIBIOTIC WISELY Inappropriate antibiotics for septic shock 5-fold reduction in survival Kumar et al. Chest 2009
12 KEY POINT #3 EARLY AND AGGRESSIVE FLUID RESUSCITATION Early fluid resuscitation improves mortality Lee et al. Crit Care Med 2012 ARISE, ProMISE, ProCESS
13 KEY POINT #3.5 FLUID RESUSCITATION CAVEATS Goal is minimum 30 ml/kg bolus Caution in patients with CHF or ESRD Consider smaller bolus and reassess volume status May need earlier transition to vasopressors
14 KEY POINT #4 SEVERE SEPSIS IS SUBTLE Evidence of organ dysfunction (attributed to sepsis) SBP < 90, MAP < 70 SBP decrease > 40 from known baseline Cr > 2.0 UOP < 0.5 ml/kg/hr for > 2 hrs Bilirubin > 2 Platelets < 100,000 INR > 1.5 or PTT > 60 secs AMS Lactate > 2
15 FLASHBACK TO 2012 Protocolizing treatment in 1 st six hours CVP 8-12 mmhg MAP 65 mmhg Urine output 0.5 ml/kg/hr ScvO 2 70% Lactate normalilzation
16 FLASHBACK TO 2012 KEY POINT #5 RESUSCITATION GOALS 2016 Protocolizing treatment in 1 st six hours CVP 8-12 mmhg MAP 65 mmhg Urine output 0.5 ml/kg/hr ScvO 2 70% Lactate normalilzation Protocolizing treatment in 1 st six hours CVP 8-12 mmhg MAP 65 mmhg Urine output 0.5 ml/kg/hr ScvO 2 70% Lactate normalilzation
17 IN STEPS THE GOVERNMENT Can we have a national standard? Three main concepts 1. Early antibiotics 2. Aggressive IVF 3. Meaningful resuscitation endpoints
18 WHAT IS A CORE MEASURE? CMS and JC partnered in 2001 Original measures: PNA, CHF, ACS, pregnancy Designed to hold hospitals accountable for standard of care Many measures come from the National Quality Foundation (NQF) Financial penalties for failing to meet core measures Hospitals scrambled to meet measures
19 CORE MEASURES Good Idea ASA for ACS Evidence-based and noncontroversial Reasonable expectation for hospitals of all sizes Bad Idea CAP Antibiotics within 4 hours of registration in CAP suspected what could go wrong? Blood cultures before antibiotics False positives?
20 SEPSIS CORE MEASURE (SEP-1) Most difficult disease to diagnosis Wide spread of disease Definitions have undergone change Don t even have accurate estimates of disease incidence Went live 10/1/15 Data collecting phase Penalties began 10/1/16 Unclear money at stake
21 WHICH PATIENTS QUALIFY? ED patients and inpatients Severe sepsis and septic shock Clock starts when: Severe sepsis/septic shock is recognized and documented by provider Registration time if presents to ED with severe sepsis/septic shock Time last criteria for severe sepsis/septic shock met Exclusions: Patients transferred from another acute-care facility Less than 18 y/o Patients placed in comfort care Patients who die within 3 hours of severe sepsis presentation or within 6 hours of septic shock presentation
22 DEFINITIONS 2 SIRS criteria plus suspected infection SIRS Temp > 101 or < 96.8 HR > 90 RR > 20 WBC > 12,000 or < 4,000 Bands > 10%
23 DEFINITIONS Severe Sepsis Sepsis plus Organ Dysfunction Evidence of organ dysfunction (attributed to sepsis) SBP < 90, MAP < 70 SBP decrease > 40 from known baseline Cr > 2.0 UOP < 0.5 ml/kg/hr for > 2 hrs Bilirubin > 2 Platelets < 100,000 INR > 1.5 or PTT > 60 secs AMS Lactate > 2 Septic Shock Severe Sepsis plus Hypoperfusion despite adequate fluid resuscitation OR Latate > 4.
24 SEVERE SEPSIS Within 3 hours: Measure serum lactate Obtain blood cultures prior to antibiotics Administer antibiotics Within 6 hours: Repeat serum lactate if initial lactate is > 2
25 SEPTIC SHOCK Within 3 hours: Measure serum lactate Obtain blood cultures prior to antibiotics Administer antibiotics 30 ml/kg crystalloid fluids Within 6 hours: Repeat volume status and tissue perfusion assessment Vasopressor administration if hypotension persists after fluid Repeat serum lactate if initial lactate is > 2
26 REPEAT ASSESSMENT OF VOLUME STATUS AND TISSUE PERFUSION: VASOPRESSORS Option 1 Focused Physical Exam Vital signs Cardiopulmonary exam Capillary refill Peripheral pulse evaluation Skin exam Option 2 Document 2 of the following: CVP ScvO2 Bedside cardiovascular ultrasound Passive leg raise or fluid challenge
27 WHY DOES THIS MAKE SENSE?
28 REASON FOR OPTIMISM Evidence of organ dysfunction (attributed to sepsis) SBP < 90, MAP < 70 SBP decrease > 40 from known baseline Cr > 2.0 UOP < 0.5 ml/kg/hr for > 2 hrs Bilirubin > 2 Platelets < 100,000 INR > 1.5 or PTT > 60 secs AMS Lactate > 2
29 WHY DOES THIS MAKE SENSE?
30 CORE MEASURE SUMMARY Core measure goal is admireable Numerous flaws to iron out Core measure or not: each hospital has to evaluate and optimize care to improve patient-centered outcomes
31 SEPSIS KEY POINTS SUMMARY Early, broad-based antibiotics Early and aggressive IVF Meaningful resuscitation endpoints Do not underestimate severe sepsis
32 QUESTIONS?
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