Daniel S. Hagg, MD

January 15, 2016

Sepsis Care and the New Core Measures

Outline What is sepsis? A brief history of sepsis care How should we take care of septic patients now? Core measures What strategies work? Advice for small hospitals

Bacteria in the Blood

Sepsis is NOT

Sepsis IS

The inflammatory response to infection

Sepsis is a major clinical problem

DISEASE NUMBER OF DEATHS/YEAR Severe Sepsis (Angus, 2001) 215,000

AMI (Minino, 2002) 193,000

Lung Cancer (Minino, 2002) 156,000

Colon Cancer (Minino, 2002) 57,000

Breast Cancer (Minino, 2002) 42,000

Minino AM, Arias E, Kochanek KD, et al. Deaths: final data for 2000. National Vital Statistics Reports Web Site.

A patient presenting with severe sepsis has a mortality risk 6-10 times greater than AMI 4-5 times greater than stroke

Diagnosis Terms to foster common dialogue

Diagnosis Sepsis = Systemic Inflammatory Response Syndrome

(SIRS) plus suspected infection Sepsis ≠ hypotension

First some definitions (you can’t treat what you don’t recognize) What is “SIRS”? Systemic inflammatory response syndrome

What is “sepsis?”

Severity of sepsis? (and why it matters) Sepsis Severe sepsis 20-35% mortality Septic shock 30-70% mortality

SIRS criteria (need ≥ 2 out of 4) • Temp >38.3C or < 36C

• HR > 90 bpm • RR >20/min or pCO2 <32 mmHg

• WBC < 4000, >12000, or >10% bands

SEPSIS is a MEDICAL EMERGENCY

• SIRS and a SUSPECTED infection

More definitions What is “severe sepsis?”

Evidence of sepsis-induced tissue hypoperfusion or organ dysfunction:

Hypotension Elevated lactate > 4 Urine output <0.5ml/kg for >2hr Acute hypoxemia (P:F ratio < 300) Altered mental status Cr >2 mg/dL Bilirubin >2mg/dL Platelet <100, INR >1.5 Paralytic ileus

What is “septic shock?”

• Severe sepsis = sepsis + any end organ damage (mortality 20-35%)

• Septic shock = severe sepsis + need for vasopressors despite fluid resuscitation

(mortality 30-70%)

Progressive Mortality can be reversed

SIRS

Date of download: 7/22/2014 Copyright © 2014 American Medical Association. All rights reserved.

From: Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients in Australia and New Zealand, 2000-2012

JAMA. 2014;311(13):1308-1316. doi:10.1001/jama.2014.2637

Mean Annual Mortality in Patients With Severe SepsisError bars indicate 95% CI.

Figure Legend:

Date of download: 7/22/2014 Copyright © 2014 American Medical Association. All rights reserved.

From: Mortality Related to Severe Sepsis and Septic Shock Among Critically Ill Patients in Australia and New Zealand, 2000-2012

JAMA. 2014;311(13):1308-1316. doi:10.1001/jama.2014.2637

Adjusted Annual Odds for the Change in Hospital Outcomes Reported as Odds Ratios Referenced Against the Year 2000When considered as a continuous variable, there was no difference between patients with severe sepsis or septic shock and other patients in the database for the

decline in mortality over time (odds ratio [OR], 0.94 [95% CI, 0.94-0.95] vs 0.94 [95% CI, 0.94-0.94]; P = .37), whereas significant differences were observed in the change over time for discharge to home (OR, 1.03 [95% CI, 1.02-1.03] vs 1.01 [95% CI, 1.01-1.01]; P < .001) and

discharge to rehabilitation facilities (OR, 1.08 [95% CI, 1.07-1.09] vs 1.09 [95% CI, 1.09-1.10]; P < .001). Discharge to rehabilitation included discharge to rehabilitation facilities and chronic care facilities such as nursing homes. ICU indicates intensive care unit.

Figure Legend:

How did we do it?

Randomized trial of usual care v. early goal directed therapy

263 patients

16% Absolute risk reduction in mortality

Goal Directed therapy 1. Recognize sepsis (give fluid bolus) 2. Administer fluids to goal CVP 3. Give vasopressors to target MAP 4. Check ScVO2 and treat accordingly

1. low with normal Hgb, give dobutamine 2. low with low hgb, give blood

Early therapy reduces mortality

ARR: 46.5 – 30.5 = 16%. Therefore NNT: 1/ARR or 1/0.16 = 6.25

Comparisons in EGDT vs. Controls

• Hospital costs decrease 22.9%

• $2,749 - $7019 per QALY

Implementation and effectiveness analysis

Survivorship has substantially increased

But now I’m told goal-directed therapy is dead

ProCESS Trial Objectives Study EGDT in multi-center format Compare 3 protocols Wild-type resuscitation Protocol guided standard care Protocol guided EGDT

Interventions

Important Highlights

Outcomes

Outcomes

Outcomes

Outcomes

What is important All of these patients received fluids equivalent to Rivers et al

EGDT 97%+ antibiotics within 6 hours >70% received antibiotics prior to enrollment

All “identified” as sepsis

Editorial

What should we do now? Our best recommendations are those of the core measures However, everything starts with EARLY recognition and a

sense of medical emergency

Identifying those at risk and making early diagnosis

Be suspicious….. The key trait for making early diagnosis is having a constantly

elevated index of suspicion Physicians need to look for sepsis in the same way they look

for stroke or AMI, in fact, it is probably more important

Some thoughts on early diagnosis

A role for lactate?

ED at Beth Israel Hospital in Boston 1287 patients with lactates drawn

Lactate up = higher mortality

More on Lactate

Blood pressure changes?

Isolated low BP?

4700 consecutive ED admissions screened for any episode of low BP

887 cases found

Episodes of hypotension

Core Measures In development since before 2007 Extremely complicated measures “specifications manual” = 63 pages long!

labelled as SEP-1

Strategies Create a culture of passion for the care of septic patients

Become an evangelist!

Take every moment to coach up the team

Sepsis care is a TEAM effort

Teach away medical mythology

create pathways and order sets that leverage current practices in other areas into best sepsis care

Common Myths 1. Avoiding Fluids in certain patient populations

1. Renal failure

2. Heart failure

2. Giving Normal Saline because the potassium is high

3. There is a “maximum” vasopressor dose

4. We give fluids to raise the blood pressure

Myth #1 I am commonly told that people “didn’t want to give too much

fluid” due to either heart failure or renal failure

The 30cc/kg bolus septic patients need is well tolerated by almost everyone.

Avoiding sufficient fluids is practicing as per the control group in Dr. Rivers goal-directed trial

Sepsis associated renal failure is much harder to reverse if we fail to restore perfusion

Myth #2 It is common to avoid Lactated Ringer’s if there is acute kidney

injury or elevated potassium due to potassium content

There is only 4mEq/L of potassium

LR is a neutral pH buffered solution vs. NS that has a pH of 4.5 and causes a hyperchloremic acidosis

Most hyperkalemia is due to acidosis related cellular shifts. correcting the acidosis fixes the hyperkalemia.

Myth #3

The patient is on “max” norepi There is simply no such thing. They need what they need. I

have used doses as high as 4mkg/kg/min (>400mkg/min) in patients who survive.

Myth # 4 Fluids are given to raise the blood pressure Fact: fluids fill the ventricles and improve stroke

volume/cardiac output. If cardiac output doesn’t increase with fluid, the patient will

NOT benefit from more fluid. Use vasopressors.

Straight leg raise

Antibiotics

Retrospective data collection at 22 centers

All patients with sepsis

Evaluated appropriate abx by whether it fit guidelines or covered eventual cultures

Outcomes

Summary Sepsis is a MEDICAL EMERGENCY

Sepsis care has evolved substantially over 15 years with significantly reduced mortality

The core of sepsis care is:

Early diagnosis

Early fluids

Early antibiotics

The new core measures reflect these data

Advice Find committed and motivated people Give them the time, tools and authority to work on this

system Support the message every day Be prepared for this to take a long time

Daniel S. Hagg Assistant Professor, Director of MICU

Director of Inpatient Quality for the Department of Medicine Oregon Health and Sciences University 503-494-6668 or Cell 503-228-0459

haggda@ohsu.edu