Surviving Sepsis

The Surviving Sepsis
Campaign:
The Sepsis Epidemic: How to Win
Sean R. Townsend, MD
Assistant Professor of Medicine
Warren G. Alpert Medical School
Brown University
Associate Director, Medical Intensive Care Unit
Rhode Island Hospital
Providence, Rhode Island
Copyright 2007 by the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, and the International Sepsis Forum.
Surviving Sepsis
Campaign
A global program to:
Reduce mortality rates
Improve standards of care
European Society of Intensive Care Medicine

International Sepsis Forum
Society of Critical Care Medicine
Surviving Sepsis
Phase 1 Barcelona declaration
Phase 2 Evidence based guidelines
Phase 3 Implementation and education
Surviving Sepsis
Phase 3 Implementation and Education
SSC Guidelines for the
Management of Severe
Sepsis
Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T,
Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker
MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM and
the SSC Management Guidelines Committee
Crit Care Med 2004;32:858-873

Intensive Care Med 2004;30:536-555
www.survivingsepsis.org
Sponsoring Organizations
•American Association of • European Society of

Critical Care Nurses Intensive Care Medicine
•American College of • European Respiratory
Chest Physicians Society
•American College of
• International Sepsis
Emergency Physicians
Forum
•American Thoracic
Society • Society of Critical Care
•Australian and New Medicine
Zealand Intensive Care • Surgical Infection
Society Society
•European Society of
Clinical Microbiology and
Infectious Diseases
Surviving Sepsis
Phase 3 Implementation and education
SSC Networks
• United States
9 California
• European Networks
9 UK (NHS)
9 Chicago
9 Ireland
9 Colorado
9 Portugal
9 New York 9 Spain
9 Kansas/Missouri(Kansas 9 Italy
City) 9 Netherlands
9 Memorial-Hermann System 9 Denmark
9 Texas 9 Poland
9 Puerto Rico
• IHI Collaborative
• Latin American Sepsis
Institute
9 Brazil
2007Chile
Copyright9 by the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, and the International Sepsis Forum.
Campaign
25% Reduction In Sepsis Mortality By
2009
• = ~ 50,000 people in the United States
each year.
• = ~ 1,100,000 individuals worldwide each
year.
Angus DC, et al. Epidemiology of severe sepsis in the United States: Analysis of incidence, outcome, and
associated costs of care. Critical Care Medicine. Jul 2001;29(7):1303-1310.
Campaign
What steps can we take?
“Sepsis” Definition
A Documented or Suspected Infection With

Two or More of the Following:
Fever (core temperature >38.3°C)
Hypothermia (core temperature <36°C)
Heart rate >90 min–1 or >2 SD above the
normal value for age
Tachypnea > 20 bpm
Leukocytosis (WBC count >12,000 µL–1)
Leukopenia (WBC count <4000 µL–1)
Normal WBC count with >10% immature forms
“Severe Sepsis” Definition
Is Defined As Sepsis Associated With Organ Dysfunction,
Hypoperfusion or Hypotension:
Organ dysfunction variables:
• Acute alteration in mental status
• Arterial hypoxemia (PaO2/FIO2 <300)
• Acute oliguria (UOP <0.5 mL·kg-1·hr-1 or 45 mmol/L for 2 hrs.)
• Creatinine > 2.0 mg/dL
• Coagulation abnormalities (INR >1.5 or aPTT >60 secs)
• Thrombocytopenia (platelet count <100,000 µL–1)
• Hyperbilirubinemia (total bilirubin > 2.0 mg/dL or 35 mmol/L)
• Hyperlactatemia (>2 mmol/L)
Hemodynamic variables:
• Arterial hypotension (SBP <90 mm Hg, MAP <65, or SBP
decrease>40 mm Hg)
Campaign
Early goal directed therapy reduced mortality
from 46.5% to 30.5%.
Rivers E, Nguyen B, Havstad S, et al. Early goal-directed

therapy in the treatment of severe sepsis and septic shock.
New England Journal of Medicine. 2001;345(19):1368-
1377.
Early Goal-Directed Therapy
for Sepsis Induced
Hypoperfusion
60 Standard therapy
EGDT
50
Mortality (%)
40
30
20
10
0
In-hospital 28-day mortality 60-day mortality
mortality NNT to prevent 1 event (death) = 6-8
(all patients)
Rivers E, et al. N Engl J Med 2001;345:1368-77

Campaign
Low dose hydrocortisone prolonged survival
in septic shock for patients with RAI.
Annane D, Sebille V, Charpentier C, et al. Effect of treatment

with low doses of hydrocortisone and fludrocortisone on
mortality in patients with septic shock. Journal of the
American Medical Association. 2002;288(7):862–871.
Annane et al. JAMA 2002; 288:862-871
Campaign
Low tidal volume ventilation reduced
mortality from 39.8% to 31%.
Ventilation with lower tidal volumes as compared with

traditional tidal volumes for acute lung injury and the acute
respiratory distress syndrome. The Acute Respiratory
Distress Syndrome Network. New England Journal of
Medicine. 2000;342(18):1301–1308.
ARDSnet
Mechanical Ventilation Protocol
Results: Mortality
40
35
30
25
% Mortality
6 ml/kg
20
12 ml/kg
15
10
5
0
The Acute Respiratory Distress Syndrome Network. N Engl J Med 2000;342:1301-1378
Campaign
Recombinant Human Activated Protein C
reduced mortality from 30.8% to 24.7%.
Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety
of recombinant human activated protein C for severe
sepsis. New England Journal of Medicine. 2001;
344(10):699–709.
Mortality and Numbers
of Organs Failing
60
50
Percent 40
Mortality 30
20
Placebo 10
rhAPC
rhAPC 0
1 2 3 4 5
Number of Organs Failing at
Entry
NEJM 2001;344:699
Campaign
Tight glycemic control reduced mortality from
8% to 4.6% and reduced mortality from
sepsis overall regardless of cause.
Van den Berghe G, Wouters P, Weekers F, et al. Intensive

insulin therapy in the critically ill patients. New England
Journal of Medicine. 2001;345(19):1359-1367.
The Role of Intensive Insulin
Therapy in the Critically Ill
100
In-hospital survival (%)

96
Intensive treatment
92
• At 12 months, intensive insulin P=0.01
therapy reduced mortality by 88
Conventional treatment
3.4% (P<0.04)
84
80
0
0 50 100 150 200 250
Days after admission
van den Berghe G, et al. N Engl J Med 2001;345:1359-67
Campaign
Timely and appropriate antibiotics reduce
mortality in critically ill patients.
Iregui M, Ward S, Sherman G, Fraser VJ, Kollef MH. Clinical
importance of delays in the initiation of appropriate
antibiotic treatment for ventilator-associated pneumonia.
Chest Journal. Jul 2002;122(1):262-268.
Leibovici L, Shraga I, Drucker M, et al: The benefit of
appropriate empirical antibiotic treatment in patients with
bloodstream infection. Journal of Internal Medicine.
1998;244(5):379–386.
Campaign
Is just agreeing to bring the

science to the bedside
enough?
A Major Study of
“Reliability” in American
Health Care…
• McGlynn, et al: The quality of health care delivered to adults in the
United States. NEJM 2003; 348: 2635-2645 (June 26, 2003)
9 439 indicators of clinical quality of care
9 30 acute and chronic conditions
9 Medical records for 6712 patients
9 Participants had received 54.9% of scientifically indicated care (Acute:
53.5%; Chronic 56.1%; Preventative 54.9%)
• Conclusion: The Defect Rate in technical quality of American health

care is approximately
45%
7 of 10 Pts Are Not
Receiving Best Care
ARDS Network Paper Published NEJM May 2000
Death decreased from 40% to 31% p= 0.007
35
31
30
25
21
20
15 12
10.3 10.5 10.3 9.6 8
10 7.7 6.9
5 2 2 2 2
0
1996 1997 1998 1999 2000 2001 2002
Median Vt ml/kg % ARDS patients with 6ml/kg Vt
(ATS-Abstract)- Brower RG et al. …. Effects on Physician Practice. Am J. Respir & CCM 2004; 169 supp:A256
Supportive and Adjunctive Therapies
Results of the German “Prevalence”
Study
100
92
Interview
79 Audit
80
67
% 60
46 Bauer M, Brunkhorst F,
Welte T, Gerlach H, Reinhart
40 K. Sepsis : Update on
31
pathophysiology, diagnostics
20
18 and therapy. Anaesthesist.
9 2006 Aug;55(8):835-45.
4
0
al ic l ne k
d
it on m v O2 s o
ti hoc
w ti a e tro Sc
r
o s
Lo ntila
yc con r oc tic
l d p
ve G Hy s e
Unreliability Causes Deaths
• Of the 150,000 ALI patients ventilated each

year in the USA 2/3rds or 100,000 are not
getting best therapy
• 9% absolute reduction means one of every

eleven patients ventilated with high Vt are
preventable deaths
• This means there are 9,000 unnecessary

deaths because of our unreliability
Campaign
Endorsing the science is not

enough.
What do we need to make this
happen?
Campaign
1. Bundles
2. An Improvement Method
3. Tracking Results
Sepsis Resuscitation Bundle
(6 hours):
1. Serum lactate measured.
2. Blood cultures obtained prior to antibiotic administration.
3. From the time of presentation, broad-spectrum antibiotics
administered within 3 hours for ED admissions and 1 hour for non-ED
ICU admissions.
4. In the event of hypotension and/or lactate > 4 mmol/L (36 mg/dl):
a) Deliver an initial minimum of 20 ml/kg of crystalloid (or colloid
equivalent).
b) Apply vasopressors for hypotension not responding to initial fluid
resuscitation to maintain mean arterial pressure (MAP) > 65 mm
Hg.
5. In the event of persistent hypotension despite fluid resuscitation
(septic shock) and/or lactate > 4 mmol/L (36 mg/dl):
a) Achieve central venous pressure (CVP) of > 8 mm Hg.
b) Achieve central venous oxygen saturation (ScvO2) of > 70%.*
* Achieving a mixed venous oxygen saturation (SvO2) of 65% is an acceptable alternative.

Sepsis Management Bundle
(24 hours):
1. Low-dose steroids administered for septic shock in
accordance with a standardized ICU policy.
2. Recombinant Activated Protein C administered in
accordance with a standardized ICU policy.
3. Glucose control maintained > lower limit of normal, but
< 150 mg/dl (8.3 mmol/L).
4. Inspiratory plateau pressures maintained < 30 cm H2O
for mechanically ventilated patients.
Critical Care Learning and Innovation
Community Storyboard and Team
Report Out
May 10-11, 2007
Baptist Memorial Hospital - Memphis
Sepsis Resuscitation
Bundle
100
90
80
70
% Patients
60
50
40
30
20
10
0
Ma 6
6
5
7
Ju 6
06
06
6
6
06
6
'0 6
07
7
7
r-0
0
r-0
t'0
c0
g'0
r'0
r' 0
p'0
c'0
v'0
b'0
y-
n-
n'
b-
ly'
ne
Oc
Ma
Ap
Ap
Ma
De
De
Ja
Au
No
Se
Fe
Ja
Fe
Ju
Month
Sepsis Management
Bundle
100
90
80
70
% Patients
60
50
40
30
20
10
0
6
6
5
7
Ju 6
06
06
6
6
06
6
'06
07
7
7
r-0
0
r-0
t'0
-0
g'0
r'0
r' 0
p'0
c'0
v'0
b'0
y-
n-
n'
ly'
b-
ne
c
Oc
Ma
Ap
Ap
Ma
De
Au
No
Ja
Ma
Se
Fe
De
Ja
Fe
Ju
Month
Mortality Rate of Patients on
Sepsis Protocol
100 100
90
80
70 67
60
% Patients
50
40 37.5
30 27 25
20 17 17
20
15 14
10 12 11
9
0 0 0 0 0 0
Ju -06
Ap 6
Ap 7
Fe 06
Au 6
Se 6
D 6
Fe 7
Ju 6
M 6
M 6
N 6
M 7
7
De 05
Ja 5
O 6
Ja 6
-0
'0
'0
r-0
0
g'0
'0
0
0
b '0
'0
r'0
0
'0
n-
ly'
n'
b-
p'
c-
p-
ar
ne
ov
ay
ar
ct
ec
Se
Month
Severe Sepsis/Septic Shock
Comparative Data- protocol versus
non-protocol
Died Discharged
2005
non-protocol 42% 58%
baseline
2006
protocol 20% 80%
Compliance with 6hr Bundle
Gao F, Fox S, Giles S, Melody T, Daniels R
Heartlands, Good Hope, Birmingham, England
100%
84%
80%
74% 74%
70%
60%
52%
40%
20%
0%
lactate blood culture antibiotics fluid+/- Hb 7-9g/dl
vasopressors
6hr Bundle & Hosp Mortality
RR=2.12 (1.2-3.8)
P=0.01 49%
50%
40%
Mortality
30% N=24/49 NNT = 3.9

23%
20%
N=12/52
10%
0%
6hr Bundle 6hr Bundle
Yes No
Compliance with 24hr Bundle
100%
80%
85%
64%
60%
43%
40%
30%
20%
0%
Glucose < 8.3 Steroids Pp < 30 RhAPC
24hr Bundle & Hosp Mortality
RR=1.75(0.84-3.6)
P=0.16 50%
50%
40%
Mortality
29% N=24/48 NNT = 4.8

30%
20%
N=6/21
10%
0%
24hr Bundle 24hr Bundle
Yes No
Standardization:
The Key to Change
9Adopt a screening tool to identify patients.
• Don’t worry about all the patients

• Processes need to mature
Protocol Development
• Protocol development takes time.
• Through iterative cycles, use feedback to improve the

protocol and obtain consensus
• Trial protocol in the clinical environment and using

iterative cycles improve the logic until it becomes
functional
• Protocol is now ready for general use
Standardization:
The Key to Change
• Protocol establishment and refinement
9Refine your use of the tool.

9Refine the tool itself based on input.
9Assign a process owner.
owner
Rollout: Segmentation
• Segment is a part of a whole.

• Define a situation that in which you should
have (some) control.
• Make that your first segment.
Segments
ICU
Wards ED ICU
Rollout: Resuscitate First
• Focus on Resuscitation Bundle first

• Rapidly (1-2 mos.) move to Implement the
Management Bundle
Model for Improvement
What are we trying to

accomplish?
How will we know that a
change is an improvement?
What change can we make that
will result in improvement?
Act Plan
Study Do
Rollout: Spread
• Spread to other segments
9Experience
9Peer to peer teaching
9Not reinventing the wheel, just small changes
to the process to smooth the way.
PDSA example:
Resuscitation Bundle
Routine use of
Resuscitation
D S bundle
P A
T A A P
D A S D
Cycle 5: ScvO2
D S
P A Cycle 4: Central venous catheter insertion
A
S P CVP target measurement
D
A P Cycle 3: Measure amount of initial fluids
S D
Resuscitation Cycle 2: Track bld cultures and antibiotic timing
Bundle
Cycle 1: Lactate on admission
PDSA example:
Lactate Collection
Lactate
Collection
D S
P A
T A A P Cycle 5: 95% Collection
D A S D
D S
P A Cycle 4: 50% Collection: introduction to
A evening and night shifts
S P
D
A P Cycle 3: Physician not alerted: Charts Tagged
S D
Screening for Cycle 2: Turnaround time unacceptable: new equipment
Severe Sepsis
Cycle 1: Lactate ordered on positive screens
Possible Rapid Cycle
Tests of Change
• Have a pre-mixed antibiotic available in
the ER
• Mark order sheets to warn versus ordering
antibiotics before blood cultures are
collected
• Others….
Possible Rapid Cycle
Tests of Change
• Change to arterial beside lactate collection

to point of care testing.
• Broker an agreement for line placement.
• Others?
Collect Data Over Time
• The ‘Plan” step includes plan to collect data
• Why collect data: to know if you are improving
• Improvement vs. Scientific Inquiry
• Record what went wrong during the data

collection
Data collection
• Voluntary submission
• Free Database
• Support: installation & ongoing issues
Data Use & Publication
• Can you publish your own results?
• What will the campaign do with data?
• IRB’s/HIPAA
Resuscitation Bundle
Management Bundle
Aggregate Data: 20 March
Bundle Compliance Moving Three Month Average
100.0%
90.0%
80.0%
70.0%
60.0%
50.0%
40.0%
30.0%
20.0%
10.0%
0.0%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Ordinal Month of Chart Presentation
Resuscitation Bundle Only Management Bundle Only Management and Resuscitaion Bundles Survival Rate Linear (Survival Rate )
PLANS for STARTING
~In Your Hospital~
• First order of business: create a template/protocol
that will work (?) in your institution.
• Get buy in from 1 Doc, 1 RN, 1 ICU.

• Describe the plan for your first test of change
• Know in advance how you will detect failure
• Team meets weekly (?). Redesign protocol,
innovate.
PLANS for STARTING
• Describe your first segment
• What is your hypothesis?
9Describe the plan for your first test of change
• Tell us how you will detect failure
• Redesign
• Describe your planned 2nd segment
• The Elevator Speech

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The Surviving Sepsis

European Society of Intensive Care Medicine

Crit Care Med 2004;32:858-873

•American Association of • European Society of

What steps can we take?

A Documented or Suspected Infection With

Rivers E, Nguyen B, Havstad S, et al. Early goal-directed

Rivers E, et al. N Engl J Med 2001;345:1368-77

Annane D, Sebille V, Charpentier C, et al. Effect of treatment

Ventilation with lower tidal volumes as compared with

The Acute Respiratory Distress Syndrome Network. N Engl J Med 2000;342:1301-1378

Van den Berghe G, Wouters P, Weekers F, et al. Intensive

In-hospital survival (%)

van den Berghe G, et al. N Engl J Med 2001;345:1359-67

Is just agreeing to bring the

• Conclusion: The Defect Rate in technical quality of American health

Median Vt ml/kg % ARDS patients with 6ml/kg Vt

• Of the 150,000 ALI patients ventilated each

• 9% absolute reduction means one of every

• This means there are 9,000 unnecessary

Endorsing the science is not

* Achieving a mixed venous oxygen saturation (SvO2) of 65% is an acceptable alternative.

30% N=24/49 NNT = 3.9

29% N=24/48 NNT = 4.8

• Don’t worry about all the patients

• Protocol development takes time.

• Through iterative cycles, use feedback to improve the

• Trial protocol in the clinical environment and using

• Protocol is now ready for general use

• Protocol establishment and refinement

9Refine your use of the tool.

• Segment is a part of a whole.

• Focus on Resuscitation Bundle first

What are we trying to

• Change to arterial beside lactate collection

• Why collect data: to know if you are improving

• Improvement vs. Scientific Inquiry

• Record what went wrong during the data

• Support: installation & ongoing issues

• Can you publish your own results?

• What will the campaign do with data?

• Get buy in from 1 Doc, 1 RN, 1 ICU.

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