Code Sepsis: Current Evidence Based Guidelines and the CMS Sepsis Core Measure Adult Patients Updated May 26, 2017

Objectives Understand history and current definitions of sepsis Understand the history and current sepsis treatment guidelines Understand the reporting and regulatory sepsis measures Understand the current and evolving UNC Code Sepsis System

Sepsis definitions

ACCP/SCCM Consensus Conference 1991 (Sepsis-1) Sepsis = Infection + two or more SIRS criteria Severe Sepsis = Sepsis + Organ dysfunction or hypo-perfusion Septic Shock = Severe sepsis with persistent hypotension despite adequate fluids

In 2001, more detailed categories added to help clinicians recognize sepsis Levy MM, Fink MP, Marshall JC, et al. 2001CCM/ESICM/ACCP/ATS/SIS InternationalSepsis Definitions Conference.Crit Care Med 2003;31:1250-6.

172 ICUs in Australia and New Zealand >100,000 patients retrospectively found from 2000-2013 with SIRS and sepsis SIRS missed 1 in 8 patients with sepsis!! No transition point in mortality with “2 or more SIRS criteria”!!

2016 Sepsis-3 REDUNDANT RETIRED

JAMA. 2016;315(8):801-810. doi:10.1001/jama.2016.0287 Task Force made up of 19 Intensivists convened to update Sepsis Definitions, understanding there’s no validated diagnostic test (Gold Standard) “The current use of 2 or more SIRS criteria to identify sepsis was unanimously considered by the task force to be unhelpful.” Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection Severe sepsis definition removed – redundant with the new sepsis definition

Suggested Clinical Criteria for Sepsis (if in ICU?) JAMA. 2016;315(8):762-774. doi:10.1001/jama.2016.0288 Suggested Clinical Criteria for Sepsis (if in ICU?) Infection + 2 or more SOFA points (above baseline) Consider Sepsis outside ICU if Infection + 2 or more qSOFA points

CBC, CMP and ABG

REALLY SICK Taskforce wanted to predict: Increased mortality JAMA. 2016;315(8):762-774. doi:10.1001/jama.2016.0288 Taskforce wanted to predict: Increased mortality Increased ICU length of stay Many difficulties with these definitions including clinical usefulness, confusion and possible delay in care, qSOFA may be very sensitive but still need specificity testing REALLY SICK

So What is Sepsis Then? Sepsis – now defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. This is a clinical diagnosis. Note that “Severe sepsis” (previously used for sepsis with organ dysfunction) is no longer recognized since it would be redundant. Septic Shock – a subset of Sepsis with circulatory and cellular/metabolic dysfunction associated with a higher risk of mortality. This is a clinical diagnosis. Sepsis and Septic Shock are medical emergencies and it is recommended that treatment and resuscitation begin immediately (Best Practice Statement).

Treatment Guidelines

Many of the same investigators involved with consensus definitions Sepsis 1 Initial Guidelines for Treatment of Sepsis Published 2004 Early Goal Directed Therapy with 3 and 6 Hour Bundles

Study Year Mortality Before (%) Mortality After (%) EGDT 1997-2000 46.5 30.5 Ani et al (Severe) 1999-2008 40.0 27.8 Kumar (Severe) 2003-2009 39.6 27.3 Kumar (Shock) 2000-2007 47.1 36.4 Mult Observational 2001-2016 40.3 27.6 ProCESS 2008-2013 18.9 19-20 ProMISE 2011-2014 25.6 24.6 ARISE 2008-2014 18.8 18.6

3 Recent Large Randomized Control Trials: Although advanced severe sepsis therapies (such as central line placement, SVO2 goals, etc) did not show improved outcomes, all were randomized after early recognition and standard therapies including antibiotics and fluid resuscitation which are the goals of UNC Code Sepsis

Don’t set it and Forget it! Data Source: A Users Guide to the 2016 Surviving Sepsis Guidelines. Society of Critical care Medicine. March 2017 Volume 45 Number 3.

Fluid Management in Sepsis Early fluid initiation improved outcomes But fluid overload at day 3 with high mortality so need Negative fluid balance at day 3 Sepsis maintenance bundle? Avoid third spacing Initiation of appropriate vasopressors

CMS Sepsis Core Measure

January 2013 October 2014

Septic Shock and Treatment Evidence Based Sepsis Treatment to Meet the CMS Sepsis Core Measure Patients > 18 Years of Age: Meeting the Measure is ALL OR NONE At UNC Hospitals target *FLAB in the first hour Sepsis and Treatment Suspected/documented infection and Life Threatening Organ Dysfunction (Creatinine >2, Lactate > 2, oliguria, new oxygen demand - respiratory distress/failure, AMS, SBP<90, RR>20) list is not all inclusive In first 3 hours: Lactate, Blood Cultures, broad spectrum Antibiotics In first 6 hours: repeat Lactate if initial > 2 Septic Shock and Treatment (Sepsis + SBP <90 not responsive to 30mL/kg IV fluid given + requires vasopressors for SBP <90 or MAP <65 + lactate >2) In first 3 hours: Lactate, Blood Cultures, broad spectrum Antibiotics, and Fluid resuscitation with 30 mL/kg crystalloid fluids In first 6 hours: repeat Lactate, complete .SEPSISEXAM, and start Norepinephrine if hypotension persists after 30 mL/kg Fluid resuscitation Renal Failure, Heart Failure, Liver Failure & Surgical patients are NOT exempt from this measure *FLAB in the first hour – Give Fluids, Result Initial Lactate, Give Antibiotics after Drawing Blood Cultures

UNC Code Sepsis

MEWS Scoring Algorithm Uses vital signs to generate an acuity score No process change or manual entry An additional tool to help identify deterioration MEWS Score is an acuity score that can be trended over time in the patient record to provide a picture of each patient’s acuity using the algorithm above. The scores are the same for each unit and hospital however the clinical response can be customized.

Color Coded Scores 1-4 5-6 7+

Sepsis Bundle Order Set

Sepsis Bundle Order Set New in March 2017 1L will not have 2 doses and 30 mL/kg NS will be IV “Bolus” and can choose time in order details

“RUN THE FLUIDS WIDE OPEN!!” We are actually asking the rapid nurses to pressure bag IV fluids in for severe shock (gets fluids in even quicker).

Sepsis Alert for ED Providers – Evaluate for Possible Sepsis “Treating Associated Infection” silences the Alert for that user for 96 hours “Treating Separate Illness” silences the alert for that user for 96 hours

Sepsis Monitor This will show a continuum of patient care even if part of time period was in the Emergency Department

Sepsis Monitor This will show a continuum of patient care even if part of time period was in the Emergency Department

Coming Soon qSOFA elements in ED Best Practice Alert SOFA scoring for ICU’s Antimicrobial Stewardship in Sepsis Inpatient Expanded Sepsis Order Set including Maintenance Bundle Elements

Add Case Examples Contact the Sepsis Core Team if your need examples sepsisfeedbackunch@unchealth.unc.edu Add Case Examples

Add current process and outcome measures Contact the Sepsis Core Team if your need updated measures sepsisfeedbackunch@unchealth.unc.edu Add current process and outcome measures

Take Home Points Suspect Sepsis Early Evaluate Patients Promptly Treat as a team event and if determine patient is septic treat as a “code sepsis” Empower nurses to call for help Use the Sepsis Bundle order sets Use .SEPSISEXAM Use your clinical judgment as you fluid resuscitate