SSC Bundle

Bambang Wahjuprajitno
ICU RSU Dr. Soetomo
Surabaya

1
 Surviving Sepsis Campaign (SSC) guidelines for
management of severe sepsis and septic shock

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
Crit Care
Care Med
Med 2004;32:858-873
2004;32:858-873
Intensive
Intensive Care
Care Med
Med 2004;30:536-555
2004;30:536-555

available
available online
online at
at
www.survivingsepsis.org
www.survivingsepsis.org
www.springerlink.com
www.springerlink.com
www.sccm.org
www.sccm.org
www.sepsisforum.com
www.sepsisforum.com

2
 But…..
• Do Physicians Practice Evidence-Based
Medicine?
• Does Research Lead to Improved Quality of
Health Care?
• Do Physicians embrace standardized care
based on published data?
• What motivates clinicians to adopt new
strategies and change clinical behavior
– Mechanical ventilation
– DVT prophylaxis

3
 Why Are Evidence-Based
Therapies Underutilized in Critical Care?

• Lack of knowledge
– Shrinking reimbursement, busier schedules, cost
• Critical Care Physicians are skeptical by
nature
– Many negative trials in critical care
• Picking and choosing evidence
• Clinical inertia
• Inability to identify appropriate candidates
• Healthcare rationing
4
 Impact of ARDSnet Protocol on Hospital
Mortality

ƒ Retrospective Review, ARDSnet hospital

ƒ Protocol group: N = 200, 2000-2003, Vt: 6.2 ± 1.1, 27.5
ƒ Historical Control: N = 92 (1998-1999), Vt: 9.8 ± 1.5, 33.8
ƒ OR: 0.32 (0.17-0.59, p = .0003)

5 Kallet et al. CCM 2005; 33:925-29

How Do We Translate Evidence-
Based Guidelines To Clinical
Practice?

6
 Changing Clinician Behavior
• Focus on Preventive health care interventions
• Five steps:
– Do an environmental scan
– Understand current behavior
– Target behavior for change
• Why, what, when, where, who
– Adopt effective strategies to change behavior
– Synergise
• Make the right thing to do the easy thing to do

7 Cook
Cook et
et al. Lancet 2004;363):1224-30
al. Lancet 2004;363):1224-30
 Phase 3:
Implementation
• Partner with Institute for Healthcare
Improvement (IHI)
– Develop sepsis management “change bundles”
• Facilitate adoption of guidelines
• Make measurement easy
– Provide opportunity for early success
• Provide education for change process
• Identify obstacles
• Provide solutions
• Facilitate outcomes reporting

8
Changing Clinical Behavior:
Converting Guidelines into
“Bundles”

9
 What are Bundles?
• A bundle is a group of precautionary steps
with approximate time and space
characteristics that, when executed collectively
and reliably, have an enhanced affect on
patient outcomes.
• The bundle provides a "forcing function" for
teamwork, and this teamwork has led to
outstanding results.

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 The Ventilator Bundle

….is a package of evidence-based

interventions that, when implemented
together for all patients on mechanical
ventilation, has resulted in dramatic
reductions in the incidence of ventilator-
associated pneumonia.

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 Ventilator Bundle (IHI)

• Head of bed elevation

• Sedation vacation
• DVT prophylaxis
• PUD prophylaxis

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 Change Bundles
• Individual elements based on solid
science
• Emphasis initially on process rather than
outcome
• Based on failure modes
• Eventual endpoint is outcome
improvement

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 Process for Bundle Development
• Review the evidence for appropriate care
(guidelines)
• Identify the important failure modes
• Define the bundle elements from a gap
analysis of defect rates
• Bundle the elements based on tasks carried out
with similar time and space characteristics
– Easy to Measure
– Linked by time

14
 Construction of a Bundle
• Pick a clinical area for improvement
• Target process change through literature review
• Perform “gap analysis” to discover where
failures in practice occur
• Build the bundle
• Evaluate performance of elements
• Evaluate compliance with bundle as a whole
• Determine outcome variables and measure

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 The Future: Sepsis Bundles
Performance Improvement Model
• Partnership with Institute of Healthcare
Improvement
• Key elements of guidelines identified that
are likely not being done currently and
would be predicted to improve outcome
• Goals and failure modes established and
linked to two time sensitive bundles (6
hour resuscitation and 24 hour
management bundle)

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 Surveillance

STUDIES INERTIA
INERTIA OF
OF
STUDIES IN
IN
THE WARD
WARD ROUTINE
ROUTINE
THE LITERATURE
LITERATURE

SURVIVOR
SURVIVOR

SSC
SSC PATIENT-CARE
PATIENT-CARE
PROGRAMS
PROGRAMS PRACTICES
PRACTICES

NON-SURVIVOR
NON-SURVIVOR
Hawthorne
Hawthorne
Effect
Effect

SURVEILLANCE
SURVEILLANCE

17 Haley
Haley RW,
RW, et al. Am
et al. Am JJ Epidemiol
Epidemiol 1990;111:474
1990;111:474 (modified)
(modified)
 Sepsis Resuscitation Bundle
To be started immediately and completed within 6 hours

• Serum lactate measured

• Blood culture obtained prior to antibiotic administration
• Broad-spectrum antibiotic administered within 3 hours of ED
admissions and 1 hour for non ED-ICU admissions
• In the event of hypotension and/or lactate > 4 mmol/L (36 mg/dl):
–– Deliver
Deliver of
of minimum
minimum 2020 ml/kg
ml/kg of
of crystalloid
crystalloid or
or colloid
colloid equivalent
equivalent
–– Apply
Apply vasopressor
vasopressor for
for hypotension
hypotension not
not responding
responding toto fluid
fluid resuscitation
resuscitation
to
to maintain
maintain mean
mean arterial
arterial pressure (MAP) ≥≥ 65
pressure (MAP) 65 mmHg
mmHg
• In the event of persistent arterial hypotension despite volume
resuscitation (septic shock) and/or initial lactate >4 mmol/L (36
mg/dl)
–– Achieve
Achieve central
central venous
venous pressure
pressure (CVP)
(CVP) ofof >> 88 mmHg
mmHg
–– Achieve
Achieve central
central venous
venous oxygen
oxygen saturation
saturation (ScvO
(ScvO22)) of
of 70%
70%

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

18 alternative
 Sepsis Resuscitation Bundle
To be started immediately and completed within 6 hours
• Serum lactate measured
• Blood culture obtained prior to antibiotic administration
• Broad-spectrum antibiotic administered within 3 hours of ED
admissions and 1 hour for non ED-ICU admissions
• In the event of hypotension and/or lactate > 4 mmol/L (36
mg/dl):
– Deliver of minimum 20 ml/kg of crystalloid or colloid equivalent
– Apply vasopressor for hypotension not responding to fluid resuscitation
to maintain mean arterial pressure (MAP) ≥ 65 mmHg
• In the event of persistent arterial hypotension despite volume
resuscitation (septic shock) and/or initial lactate >4 mmol/L
(36 mg/dl)
– Achieve central venous pressure (CVP) of > 8 mmHg
– Achieve central venous oxygen saturation (ScvO22) of 70%

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 Sepsis Management Bundle
To be started immediately and completed within 24 hours

• Low dose steroid administered for septic shock

in accordance with a standardized ICU policy
• Drotrecogin alfa (activated) administered in
accordance with a standardized ICU policy
• Glucose control maintained > lower limit of
normal, but < 150 mg/dl (8.3 mmol/L)
• For mechanically ventilated patients inspiratory
plateau pressure maintained < 30 mmH22O

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 Impact of Sepsis Bundle Compliance
Gao
Gao F,
F, Fox
Fox S,
S, Giles
Giles S,
S, Melody
Melody T,
T, Daniels
Daniels R
R
Heartlands,
Heartlands, Good
Good Hope,
Hope, Birmingham,
Birmingham, England
England

• Sample size:
– 101 consecutive adult patients
• Duration:
– 1st Nov. 2004 - 31st March 2005
• Settings:
– Two acute NHS Trust hospitals in England

21 Gao F,et al. Crit care 2005;8:R764-R770

 Compliance of 6-h Bundle
Gao
Gao F,
F, Fox
Fox S,
S, Giles
Giles S,
S, Melody
Melody T,
T, Daniels
Daniels R
R
Heartlands,
Heartlands, Good
Good Hope,
Hope, Birmingham,
Birmingham, England
England

100%
100%
84%
84%
80%
80% 74%
74% 74%
74% 70%
70%
60%
60% 52%
52%

40%
40%

20%
20%

0%
0%
lactate
lactate blood
blood culture
culture antibiotics
antibiotics fluid+/-
fluid+/- Hb
Hb 7-9g/dl
7-9g/dl
vasopressors
vasopressors

22 Gao F,et al. Crit care 2005;8:R764-R770

 6-hr Bundle & H-Mortality
Gao
Gao F,
F, Fox
Fox S,
S, Giles
Giles S,
S, Melody
Melody T,
T, Daniels
Daniels R
R
Heartlands,
Heartlands, Good
Good Hope,
Hope, Birmingham,
Birmingham, England
England

RR=2.12 (1.2-3.8)
P=0.01 49%
50%
50%

40%
40%
Mortality

30%
30% 23%
N=24/49 NNT = 3.9
20%
20%

10%
10% N=12/52

0%
0%
6-hr
6-hr bundle-
bundle- Yes
Yes 6-hr
6-hr bundle-
bundle- No
No

23 Gao F,et al. Crit care 2005;8:R764-R770

 6-hr Bundle & ICU Mortality
Gao
Gao F,
F, Fox
Fox S,
S, Giles
Giles S,
S, Melody
Melody T,
T, Daniels
Daniels R
R
Heartlands,
Heartlands, Good
Good Hope,
Hope, Birmingham,
Birmingham, England
England

RR=1.93 (1.1-3.5)
P=0.045 55%
60%
60%

50%
50%

40%
40%
Mortality

29%
NNT = 3.9
30%
30%
N=16/29
20%
20%
N=12/42
10%
10%

0%
0%
6-hr
6-hr bundle-
bundle- Yes
Yes 6-hr
6-hr bundle-
bundle- No
No

24 Gao F,et al. Crit care 2005;8:R764-R770

 Compliance of 24-h Bundle
Gao
Gao F,
F, Fox
Fox S,
S, Giles
Giles S,
S, Melody
Melody T,
T, Daniels
Daniels R
R
Heartlands,
Heartlands, Good
Good Hope,
Hope, Birmingham,
Birmingham, England
England

100%
100%
85%
85%
80%
80%
64%
64%
60%
60%
43%
43%
40%
40% 30%
30%

20%
20%

0%
0%
Glucose
Glucose <8.3
<8.3 Steroids
Steroids Pp
Pp << 30
30 APC
APC

25 Gao F,et al. Crit care 2005;8:R764-R770

 24-hr Bundle & H-Mortality
Gao
Gao F,
F, Fox
Fox S,
S, Giles
Giles S,
S, Melody
Melody T,
T, Daniels
Daniels R
R
Heartlands,
Heartlands, Good
Good Hope,
Hope, Birmingham,
Birmingham, England
England

RR=1.75(0.84-3.6)
P=0.16 50%
50%
50%
Mortality

40%
40%
29%
NNT = 4.8
30%
30%
N=24/48
20%
20%
N=6/21
10%
10%

0%
0%
24-hr
24-hr bundle-
bundle- Yes
Yes 24-hr
24-hr bundle-
bundle- No
No

26 Gao F,et al. Crit care 2005;8:R764-R770

 Surviving Sepsis Campaign: Phase III
• A Global, multi-center, 2 year trial
– Multiple hospital networks
• Before/after design
• Primary Outcome
– The impact of a model for changing bedside
management of sepsis
• Secondary Outcome
– Mortality

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 The Surviving Sepsis Campaign Network
Hospitals
• Networks of Hospitals in global regions
– Hospitals may enter data as individual hospitals or as a network
– Data may be sent as patient level data or aggregate data
•• Without
Without patient
patient identifiers
identifiers
• Minimum data set:
– Bundle elements without variation
– Hospitals may add data elements
• Reports:
– Monthly or quarterly
– By hospital and network
• Hospital and regional data owned by network
– Free to publish after data collection period completed

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 Networks Materials
Website Data Collection tool
How to create change Paper vs. direct to
teams database
Bundles
Changes Database
Measures
Regional reporting
Educational Materials
Automated uploading
User Manual
Facilitate website
navigation
Improvement stories

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 SSC Network

United States Europe

Colorado UK
NYCHHC SICS/SICSAG
NYSHEA UKICS
Sutter Health Ireland
Memorial Herman ICSI
VISICU sites France
Latin American Portugal
Spain
Sepsis Institute

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SSC Chart Review Database
Software

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 Chart review database

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 Evaluation for severe sepsis screen tool

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 Sepsis presentation screen

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 Lab work/antibiotic administration screen

35
 Blood pressure management screen

36
 CVP/ScvO2 screen

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 Steroid/RhAPC Administration Screen

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 Glucose/Ventilation Screen

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 Median Glucose/Pplat Calculation Worksheet

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 Discharge Screen

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 Resuscitation Bundle Compliance Screen

42
 Management Bundle Compliance Screen

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 Monthly Quality Indicator Report

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 Monthly Quality Indicator Report

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 Conclusions
• SSC recommendations are based on evidence
based studies
• To be implemented in the clinical practice the
guidelines has been translated into SSC
Bundles to monitor the process of care
• Implementing SSC guidelines in the
management of patient with severe sepsis and
septic shock could improve the patient care
and decreasing mortality

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 Thank you 4 your kind attention!

www.survivingsepsis.org
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