OHSU. Update in Sepsis

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1 Update in Sepsis Jonathan Pak, MD June 1, 2017

2 Structure of Talk 1. Sepsis-3: The latest definition 2. Clinical Management - Is EGDT dead? - Surviving Sepsis Campaign Guidelines 3. A novel therapy: Vitamin C

3 Sepsis-3

4 Hippocrates claimed that sepsis (σῆψις, putrefaction ) was the process by which flesh rots, swamps generate foul airs, and wounds fester. 4

5 Challenges of Defining Sepsis Symptoms are often vague Sepsis is a broad term applied to an incompletely understood process No biological, imaging, or lab features are unique to a septic patient 5

6 6

7 Issues with 1991 & 2001 Definitions SIRS Based Problems with using SIRS to define sepsis: Not specific to infection Appropriate stress response Is not effective at predicting outcomes 7

8 SIRS: Common and Nonspecific Am J Respir Crit Care Med 2015; 192:

9 SIRS: Not Sensitive for Sepsis New Engl J Med 2015; 372:

10 Issues with 1991 & 2001 Definitions SIRS Based Confusing: sepsis vs severe sepsis What prior definitions labeled sepsis, most would call infection No explicit clinical criteria for septic shock Mortality from septic shock has ranged from 20-60% in recent major studies 10

11 11

12 Singer M, Deutschman CS, Seymour CW, Shankar-Hari M et al Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) JAMA 2016; 315:

13 Task Force Consensus Decisions 1. Out of scope to define infection 2. Sepsis is not simply infection + two or more SIRS 3. The host response is key 4. Sepsis represents bad infection (bad = leading to organ dysfunction) 5. Severe sepsis is unhelpful and should be eliminated 13

14 Sepsis-3 Definition Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection 14

15 Operationalizing the definition Life-threatening organ dysfunction caused by a dysregulated host response to infection Infected Septic There is not a gold standard for sepsis Task force used really sick as a proxy Infected Really Sick To define really sick, they used: Hospital Mortality Prolonged ICU Stay 15

16 Clinical Criteria Studied SIRS 0-4 points (Temp, HR, RR, WBC count) SOFA (Sequential Organ Failure Assessment) 0-24 points (13 variables, labs, and therapeutics) LODS (Logistic Organ Dysfunction System) 0-22 points (similar to SOFA) 16

17 Sources of Data Used 17 >800,000 Electronic Health Record Encounters 177 hospitals (primarily US), which included: community and academic rural, suburban, and urban public, private, and federal ICU, ward, ED, and prehospital

18 Results from Analysis SOFA and LODS had greater predictive validity than SIRS in identifying really sick SOFA comparable to LODS (but SOFA simpler) SOFA Score 2 associated with ~10% mortality (mortality rate for STEMI: ~8%) 18

19 Sepsis-3 Definition Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection Clinical criteria for sepsis Suspected infection + SOFA 2 (or change in SOFA 2) 19

20 SOFA Score Respiratory 400 <400 <300 <200 <100 PaO2/FIO2 Coagulation Platelets, x <150 <100 <50 <20 Liver < >12.0 Bilirubin dopa , dopa >15, dopamine <5, CV MAP 70 MAP <70 epi 0.1, epi >0.1 dobutamine norepi 0.1 norepi >0.1 CNS GCS Score <6 Renal Creatinine (or UOP) < (<500 ml/d) >5.0 (<200 ml/d)

21 Developing New Criteria Focus on speed of assessment, ease of use Studied 21 variables from Sepsis-2 Multivariable logistic regression for in-hospital mortality 21

22 What is qsofa? GCS < 15 RR 22 SBP 100 qsofa.com 22

23 qsofa in Patients with Suspected Infection ICU Encounters Non-ICU Encounters 23

24 Mortality in Non-ICU Patients Risk of Mortality (%) qsofa Score 24

25 How Does qsofa Compare? In the ICU, SOFA and LODS had greater predictive validity than qsofa Outside the ICU, qsofa had similar predictive validity to the more complex scores 25

26 Sepsis-3 Definition Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection Clinical criteria for sepsis Suspected infection + SOFA 2 (or change in SOFA 2) Prompt outside the ICU to consider sepsis Suspected infection + qsofa 2 26

27 Points of Confusion qsofa sepsis qsofa is primarily a risk stratification tool Can use lactate with qsofa qsofa of 1 + lactate > 2 is similar to qsofa of 2 Don t wait to treat patients until qsofa is 2 qsofa is not a management trigger! 27

28 Clinical uses for qsofa Tool to help guide triage Identifying patients who might need increased monitoring, workup for organ injury A prompt to consider infection when it had not been 28

29 Retrospective, single center cohort study >30,000 patients with suspected infection (ED, ward) Compared qsofa to other early warning scores (SIRS, NEWS, and MEWS) in predicting death and ICU transfer 29 Am J Respir Crit Care Med Apr 1;195(7):

30 qsofa more specific, but less sensitive than SIRS For most patients who required ICU transfer or died: 2 SIRS criteria met 17 hours prior 2 qsofa criteria met 5 hours prior Neither were as accurate as NEWS or MEWS 30 Am J Respir Crit Care Med Apr 1;195(7):

31 Accuracy of different algorithms for predicting ICU transfer or Death 31 Am J Respir Crit Care Med Apr 1;195(7):

32 National Early Warning Score (NEWS)

33 Sepsis-3 Definition: Septic Shock Subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone. Clinical criteria for septic shock Despite adequate fluid resuscitation Vasopressors necessary to maintain MAP 65 AND Lactate >2 mmol/l 33

34 Lactate and Mortality in Septic Shock 34

35 Why hypotension and elevated lactate? 35

36 Recommended Primary ICD Codes ICD-9 ICD-10 Sepsis R65.20 Septic Shock R

37 Sepsis-3 Strengths Objectivity: data driven criteria Generalizable: readily measurable criteria should improve reproducibility in further research Ease of use: qsofa: rapid bedside assessment SOFA: clinical measures and lab tests performed in any sick patient, calculation can be automated Definitions have predictive validity for mortality 37

38 Sepsis-3 Limitations Task force could not achieve consensus on all points Requires calculations of SOFA scores Needs to be prospectively validated Prelim studies showing problems with qsofa Not a consensus statement (IDSA, ACCP, others have not endorsed it) 38

39 Early Goal-Directed Therapy

40 40 N Engl J Med Nov 8;345(19):

41 ProCESS ProMISe ARISE Patients Primary Outcome 60 day Mortality 90 day Mortality 90 day Mortality 41

42 5 studies representing 4,735 patients Looked at mortality and ICU utilization EGDT showed no benefit over usual care, but associated with increased ICU transfer and vasopressor use 42 Intensive Care Med Sep;41(9):

43 Primary Mortality Outcome Rivers 2001 Jones 2010 ProCESS 2014 ARISE 2014 ProMISe 2015 Favors EGDT Favors Control 43 Intensive Care Med Sep;41(9):

44 90 Day Mortality ProCESS 2014 ARISE 2014 ProMISe 2015 Favors EGDT Favors Control 44 Intensive Care Med Sep;41(9):

45 ICU Admission ProCESS 2014 ARISE 2014 ProMISe 2015 Favors EGDT Favors Control 45 Intensive Care Med Sep;41(9):

46 ICU Length of Stay Jones 2010 ProCESS 2014 ARISE 2014 ProMISe 2015 Favors EGDT Favors Control 46 Intensive Care Med Sep;41(9):

47 EGDT showed no benefit over usual care, but was associated with increased ICU transfer and vasopressor use 47 Intensive Care Med Sep;41(9):

48 Prospectively designed meta-analysis of individual patient data from ProCESS, ProMISe, and ARISE Looked at mortality at 90 days and 1 year, organ support, and cost Looked for interactions in subgroups of 16 patient characteristics, 6 care-delivery characteristics 3723 patients at 138 hospitals in seven countries EGDT did not result in better outcomes, but was associated with higher costs Subgroup analysis showed no benefit for patients with worse shock or higher APACHE II scores, or for hospitals more or less likely to use fluids, vasopressors 48 N Engl J Med Mar 21.

49 Surviving Sepsis Campaign: 2016 Recommendations

50 50

51 Initial Resuscitation Finally dropped recommendation for EGDT At least 30 ml/kg crystalloid in first 3 hours (strong recommendation, low quality of evidence) Additional fluids guided by frequent hemodynamic reassessment (best practice statement) 51 Crit Care Med Mar;45(3):

52 Diagnosis Obtain microbiologic cultures (including blood) before abx if it does not substantially delay starting abx (best practice statement) Achieve anatomic diagnosis requiring source control, and implement source control intervention, ASAP (best practice statement) 52 Crit Care Med Mar;45(3):

53 Antimicrobial therapy Initiation within 1 hour (strong recommendation, moderate quality of evidence) Empiric, broad spectrum therapy with 1 or more agents (strong recommendation, moderate quality of evidence) For septic shock, combination therapy with at least two antimicrobial classes (weak recommendation, low quality of evidence) Do not use combination therapy routinely for other serious infections (bacteremia, sepsis without shock) (weak recommendation, low quality of evidence) 53 Crit Care Med Mar;45(3):

54 Antimicrobial therapy (continued) Narrow empiric antimicrobials once pathogen sensitivities established and/or adequate clinical improvement noted (best practice statement) 7-10 days sufficient for most serious infections (weak recommendation, low quality of evidence) Daily assessment for de-escalation of antimicrobials (best practice statement) Procalcitonin can be used to support shortening duration of antimicrobial therapy (weak recommendation, low quality of evidence) 54 Crit Care Med Mar;45(3):

55 Fluid Therapy Crystalloids are fluid of choice (strong recommendation, moderate quality of evidence) Albumin suggested in addition when patients require substantial amounts of crystalloids (weak recommendation, low quality of evidence) 55 Crit Care Med Mar;45(3):

56 Vasoactive Agents Target MAP >65 (strong recommendation, moderate quality of evidence) Norepinephrine is first vasopressor of choice (strong recommendation, moderate quality of evidence) Can add vasopressin (up to 0.03 units/min) or epinephrine to achieve MAP goal (weak recommendation, low quality of evidence) 56 Crit Care Med Mar;45(3):

57 Shock not resolving quickly Further hemodynamic assessment (e.g. cardiac function) to determine type of shock (best practice statement) Dynamic variables over static to assess fluid responsiveness (weak recommendation, low quality of evidence) 57 Crit Care Med Mar;45(3):

58 Vitamin C

59 59

60 60

61 Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J 61 Chest Dec 6. pii: S (16)

62 Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study Retrospective, single center, before-after study Pts with severe sepsis or septic shock and procalcitonin >2 ng/ml 47 consecutive pts from June Dec 2015 vs 47 consecutive pts from Jan July 2016 Treatment arm received: IV vitamin C (1.5 g q6h) IV thiamine (200 mg q12h) IV hydrocortisone (50 mg q6h) 62 Chest Dec 6. pii: S (16)

63 Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study 63 Chest Dec 6. pii: S (16)

64 Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study 64 Chest Dec 6. pii: S (16)

65 65

66 66

67 Conclusions A new definition for sepsis has been proposed, but has not yet achieved widespread adoption Significant evidence has accumulated that EGDT does not improve outcomes, and it is no longer recommended There is increasing interest in the promise of vitamin C in treating sepsis, but it is still considered experimental 67

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