SSC Point Prevalence Study Sepsis Protocol v7 .pdf



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Surviving  Sepsis  Campaign  
 
 
An  International  Multicentre  Prevalence  Study  on  Sepsis.  
 
 
Project  Protocol  
 
 
 

 

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SSC study protocol version 7

Table  of  Contents  
1.   Trial  Coordination  and  Management  ................................................................................................  3  
1.1.   Chief  investigators  .....................................................................................................................  3  
1.2.   Steering  committee  ...................................................................................................................  3  
1.3.   National  and  Regional  Coordinators  ..........................................................................................  3  
2.   Introduction  ......................................................................................................................................  4  
2.1.   The  Surviving  Sepsis  Campaign  ..................................................................................................  4  
2.2.   Project  Aims  ...............................................................................................................................  6  
2.3.   Rationale  ....................................................................................................................................  6  
3.   Methods  ............................................................................................................................................  6  
3.1.   Inclusion  criteria  .........................................................................................................................  6  
3.2.   Exclusion  criteria  ........................................................................................................................  7  
3.3.   Definitions  ..................................................................................................................................  7  
3.4.   Table  1  Diagnostic  Criteria  for  Sepsis  .........................................................................................  7  
3.5.   Table  2.  Definition  of  Severe  Sepsis  ...........................................................................................  8  
3.6.   Centres  .......................................................................................................................................  8  
3.7.   Ethics/IRB  review  .......................................................................................................................  8  
3.8.   Data  collection  and  collation  .....................................................................................................  9  
3.9.   Dataset  .......................................................................................................................................  9  
3.10.   Statistical  analysis  ..................................................................................................................  10  
3.11.   Sample  size  analysis  ...............................................................................................................  10  
3.12.   Study  timeline  ........................................................................................................................  10  
3.13.   Organisation  ..........................................................................................................................  10  
3.14.   National  /  Local  co-­‐ordinators  ...............................................................................................  11  
3.15.   Local  co-­‐ordinators  ................................................................................................................  11  
3.16.   Data  management  and  ownership  ........................................................................................  11  
3.17.   Publication  plan  .....................................................................................................................  12  
3.18.   Deliverables  ...........................................................................................................................  12  
4.   References  .......................................................................................................................................  13  
 

 

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SSC study protocol version 7

1. Trial  Coordination  and  Management  
 
1.1. Chief  investigators  
Andrew  Rhodes  &  Mitchell  Levy  
 
1.2. Steering  committee  
Richard  Beale  
Jean  Daniel  Chiche    
Daniel  De  Backer  
Laura  Evans    
Chris  Farmer    
Ricardo  Ferrer  
Mitchell  Levy  
Andrew  Rhodes    
Carol  Thompson    
 
1.3. National  and  Regional  Coordinators  
 

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2. Introduction  
2.1. The  Surviving  Sepsis  Campaign  
As  the  Surviving  Sepsis  Campaign  marks  10  years  of  progress  with  the  publication  of  the  third  edition  
of  its  “International  Guidelines  for  Management  of  Severe  Sepsis  and  Septic  Shock,”  we  are  gratified  to  
reflect  on  what  has  been  achieved  through  committed  participation  in  the  Campaign  by  clinicians  
worldwide.  Despite  these  achievements,  sepsis  remains  a  disorder  of  epidemic  incidence  and  severe  
consequences  with  an  unacceptably  high  death  rate  and  devastating  long-­‐term  effects  (1-­‐2).  
Application  of  sepsis  care  bundles  has  reduced  mortality  in  hospitals  that  signed  up  to  the  Surviving  
Sepsis  Campaign,  but  the  number  of  hospitals  involved  has  remained  low.  We  also  recognize  the  
possibility  that  the  guidelines  may  not  be  applicable  for  those  patients  whose  care  is  delivered  in  
under-­‐resourced  environments.    We  are,  therefore,  compelled  to  delineate  new  steps  that  will  save  
many  more  lives.    
The  original  goal  of  the  Campaign  was  to  reduce  mortality  from  severe  sepsis  and  septic  shock  by  25%.  
Activities  toward  this  goal  included:  


Developing  evidence-­‐based  guidelines  for  appropriate  care  



Improving  diagnosis  



Educating  healthcare  professionals  



Increasing  the  use  of  appropriate  treatment  



Building  awareness  of  sepsis  

 
The  Campaign  proceeded  in  three  phases:    
Phase  I:    Introduction  of  the  Campaign-­‐-­‐Following  the  announcement  of  the  target  in  2002,  
awareness  of  the  incidence  and  prevalence  of  the  condition  became  heightened.    Although  clinicians  
were  more  attuned  to  the  signs  of  sepsis,  a  need  to  enhance  the  recognition  among  patients  and  their  
families  was  observed  (3).  
Phase  II:    Publication  of  the  Guidelines-­‐-­‐In  June  2003,  representatives  from  11  international  societies  
convened  to  develop  an  evidence-­‐based  set  of  guidelines  for  the  management  of  severe  sepsis  and  
septic  shock.    With  publication  of  this  document  in  2004  (4),  the  Campaign  initiated  an  educational  
effort  to  disseminate  the  knowledge  and  recommendations  widely.    An  updated  set  of  guidelines,  
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published  in  2008,  was  sponsored  by  26  professional  societies  (5).    The  current,  third,  edition,  which  
reflects  the  latest  evidence  related  to  sepsis  treatment  and  involves  30  organizations,  appears  in  the  
February  2013  issues  of  Critical  Care  Medicine  and  Intensive  Care  Medicine  (6).  The  Surviving  Sepsis  
Campaign  Guidelines  have  become  the  gold  standard  for  sepsis  care  as  they  are  incorporated  into  
hospital  protocols  and  regulatory  mandates  internationally.    
Phase  III:    Guideline  Implementation,  Data  Collection,  and  Behavior  Change-­‐-­‐  Drawing  on  the  
expertise  in  quality  improvement  gained  through  partnering  with  the  Institute  for  Healthcare  
Improvement,  we  constructed  the  Surviving  Sepsis  Campaign  Care  Bundles  from  key  guideline  
recommendations.  Subsequent  development  and  distribution  of  a  data  collection  tool  along  with  a  
website,  online  discussion  forum,  implementation  manual,  newsletter,  and  a  series  of  educational  
meetings  enabled  local  and  regional  networks  of  hospitals  worldwide  to  document  and  improve  
performance.    
The  Significant  Results  
A  recent  analysis  of  more  than  25,000  patient  charts  from  186  hospitals  over  a  5-­‐year  period  confirms  
the  initial  statement  that  ongoing  hospital  participation  in  the  Campaign  is  associated  with  continuous  
quality  improvement  and  a  sustained,  linear  decrease  in  mortality  (7,8).  Despite  the  evidence  
demonstrating  the  value  of  using  performance  metrics  for  maintaining  standards  of  care  for  the  
management  of  sepsis,  marked  differences  remain  between  hospitals  in  the  delivery  of  care  for  septic  
patients  (9).  Published  data  clearly  show  that  delays  in  the  recognition  and  treatment  of  sepsis  are  
associated  with  worse  outcomes  while  early  treatment  improves  survival  (10).    Reviewing  the  
inconsistent  application  of  measures  identifies  an  important  opportunity  to  reduce  sepsis-­‐induced  
mortality  further.    In  particular,  earlier  identification  of  patients  who  develop  sepsis  on  the  wards  and  
improvements  in  the  timely  application  of  evidence-­‐based,  validated  therapies  represents  a  unique  
opportunity  to  save  additional  lives.      
Future  Needs  
Despite  the  successes,  it  is  recognized  that  the  penetration  of  the  campaign  to  hospitals  around  the  
world  and  the  patients  they  treat  is  not  good.    To  inform  current  and  future  quality  improvement  
efforts  in  sepsis  globally,  there  is  a  need  to  better  understand  how  patients  presenting  with  severe  
sepsis  are  treated,  how  the  individual  elements  of  the  evidence-­‐based  Surviving  Sepsis  Campaign  
bundles  are  used  in  different  geographic  areas  and  how  these  may  relate  to  outcome.    A  critical  step  in  
quality  improvement  efforts  is  a  thorough  assessment  of  current  practice  in  order  to  identify  ongoing  
gaps  in  clinical  practice.    This  project  is  designed  to  address  this  need.  
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2.2. Project  Aims  
1. Establish  an  estimate  of  the  global  burden  of  sepsis  by  determining  the  prevalence  of  sepsis,  
severe  sepsis  and  septic  shock  throughout  the  world  presenting  to  critical  care  units    
2. Assess  practice  gaps  in  care  of  patients  with  sepsis  by  measuring  compliance  with  SSC  sepsis  
guidelines  and  bundles  in  sites  in  both  community  and  academic  hospitals  internationally.    
3. To  evaluate  the  impact  of  sepsis,  severe  sepsis  and  septic  shock  on  outcome    
4. Estimate  sample  size  requirements  to  detect  meaningful  differences  in  patient-­‐centered  
outcomes  for  clinical  trials  performed  in  a  large,  international  research  network.  
 
2.3. Rationale  
Previously  collected  data  on  sepsis  and  septic  shock  is  now  old  (11,12)  and  with  recent  changes  in  
clinical  practice  together  with  the  impact  of  the  SSC,  the  data  needs  updating.    Identification  of  
practice  gaps  in  sepsis  care  will  inform  current  and  future  quality  improvement  initiatives  globally.  
 
3. Methods  
A  prospective,  observational,  quality  improvement  project  of  the  prevalence  of  patients  presenting  to  
intensive  care  with  either  severe  sepsis  or  septic  shock  and  compliance  with  evidence-­‐based  practices.    
 
3.1. Inclusion  criteria  
For  the  study  day  (0000  to  2400),  consecutive  patients  presenting  to  either  the  emergency  department  
(ED)  or  being  cared  for  in  the  ICU  (either  intermediate  care  or  intensive  care)  with  severe  sepsis  or  
septic  shock  will  be  enrolled.  To  be  eligible  patients  must  have  all  of  the  following:  
1. Must  be  admitted  or  transferred  to  either  the  ED  or  an  Intensive  Care  Unit.      
2. Have  a  high  clinical  suspicion  of  an  infection  
3. Have  sepsis  as  defined  by  the  presence  (probable  or  documented)  of  infection  together  
with  systemic  manifestations  of  infection  
4. Evidence  of  acute  organ  dysfunction  and  /  or  shock  

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3.2. Exclusion  criteria  
The  following  will  be  excluded:  
1. Patients  less  than  18  years  of  age  
2. Any  patients  previously  included  in  the  study  during  the  same  study  period  
 
3.3. Definitions  


Sepsis  is  defined  as  the  presence  (probable  or  documented)  of  infection  together  with  
systemic  manifestations  of  infection.    



Severe  sepsis  is  defined  as  sepsis  plus  sepsis-­‐induced  organ  dysfunction  or  tissue  
hypoperfusion  (Tables  1  and  2).  



Sepsis-­‐induced  hypotension  (shock)  is  defined  as  a  systolic  blood  pressure  (SBP)  <  90mm  Hg  
or  mean  arterial  pressure  (MAP)  <  70mm  Hg  or  a  SBP  decrease  >  40mm  Hg  or  less  than  two  
standard  deviations  below  normal  for  age  in  the  absence  of  other  causes  of  hypotension.  
 

3.4. Table  1  Diagnostic  Criteria  for  Sepsis  
Infection,  documented  or  suspected,  and  some  of  the  following:  
1. General  variables  








Fever  (>  38.3°C)  
Hypothermia  (core  temperature  <  36°C)  
Heart  rate  >  90/min  
Tachypnea  
Altered  mental  status  
Significant  edema  or  positive  fluid  balance  (>  20mL/kg  over  24  hr)  
Hyperglycemia  (plasma  glucose  >  140  mg/dL  or  7.7  mmol/L)  in  the  absence  of  diabetes  

2. Inflammatory  variables  








Leukocytosis  (WBC  count  >  12,000  μL–1)  
Leukopenia  (WBC  count  <  4000  μL–1)  
Normal  WBC  count  with  greater  than  10%  immature  forms  
Plasma  C-­‐reactive  protein  more  than  two  SD  above  the  normal  value  
Plasma  procalcitonin  more  than  two  SD  above  the  normal  value  
Hemodynamic  variables  
Arterial  hypotension  (SBP  <  90mm  Hg,  MAP  <  70mm  Hg,  or  an  SBP  decrease  >  40mm  Hg  in  
adults  or  less  than  two  SD  below  normal  for  age)  

3. Organ  dysfunction  variables  
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Arterial  hypoxemia  (Pao2  /Fio  2<  300)  
Acute  oliguria  (urine  output  <  0.5  mL/kg/hr  for  at  least  2  hrs  despite  adequate  fluid  
resuscitation)  
Creatinine  increase  >  0.5  mg/dL  or  44.2  μ  mol/L  
Coagulation  abnormalities  (INR  >  1.5  or  aPTT  >  60  s)  
Ileus  (absent  bowel  sounds)  
Thrombocytopenia  (platelet  count  <  100,000  μL–1)  
Hyperbilirubinemia  (plasma  total  bilirubin  >  4mg/dL  or  70  μmol/L)  

4. Tissue  perfusion  variables  



Hyperlactatemia  (>  1  mmol/L)  
Decreased  capillary  refill  or  mottling  
 

 
3.5. Table  2.  Definition  of  Severe  Sepsis  
Severe  sepsis  definition  =  sepsis-­‐induced  tissue  hypoperfusion  or  organ  dysfunction  (any  of  the  
following  thought  to  be  due  to  the  infection)  
• Sepsis-­‐induced  hypotension  
• Lactate  above  upper  limits  laboratory  normal  
• Urine  output  <  0.5mL/kg/hr  for  more  than  2  hrs  despite  adequate  fluid  resuscitation  
• Acute  lung  injury  with  PaO2/FIO2  <  250  in  the  absence  of  pneumonia  as  infection  source  
• Acute  lung  injury  with  PaO2/FIO2  <  200  in  the  presence  of  pneumonia  as  infection  source  
• Creatinine  >  2.0mg/dL  (176.8  μmol/L)  
• Bilirubin  >  2mg/dL  (34.2  μmol/L)  
• Platelet  count  <  100,000  μL  
• Coagulopathy  (international  normalized  ratio  >  1.5)  
 
3.6. Centres  
This  international  quality  improvement  project  aims  to  recruit  as  many  centres  as  possible.  
For  this  study  a  network  of  coordinators  will  be  identified.  It  will  be  the  task  of  this  group  of  individuals  
to  enrol  sites  within  their  own  country,  to  ensure  the  necessary  regulatory  approvals  are  in  place  and  
to  coordinate  the  local  communication.    
 
3.7. Ethics/IRB  review  
Ethics  or  IRB  approval  may  not  be  required  in  all  participating  nations  or  sites.  Centres  will  not  be  
permitted  to  record  data  unless  ethics  approval  or  an  equivalent  waiver  is  in  place.  Each  individual  site  
is  responsible  for  appropriate  materials  for  Ethics  Board  or  IRB  review.    This  quality  improvement  
initiative  is  in  effect  a  large-­‐scale  clinical  audit.    
 
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3.8. Data  collection  and  collation  
Data  will  be  collected  in  the  intensive  care  unit  and  also  in  the  ED.  Any  patient  will  only  be  included  in  
the  study  once  (therefore  if  the  patient  is  admitted  through  the  ED  to  the  ITU,  only  one  case  report  
form  (CRF)  will  be  completed).  
A  local  site  investigator  will  enter  relevant  de-­‐identified  patient-­‐specific  data  into  an  online  electronic  
case  report  form  (eCRF).    No  identifiable  data  will  be  submitted  to  the  online  database  housed  on  a  
secure  server  in  Germany.    Data  will  be  published  in  aggregated  form  only.      
Data  will  be  collected  in  individual  centres  on  paper  case  record  forms  (CRFs)  or  directly  into  the  web-­‐
based  electronic  case  report  form.      Upon  entry  into  the  eCRF,  each  patient  will  be  assigned  a  unique  
study  identifier.    Local  sites  will  maintain  a  link  between  the  unique  study  identifier  and  the  patient  for  
30  days  in  order  complete  outcome  follow  up.    This  link  kept  secure  at  each  site,  will  not  be  submitted  
or  transmitted  online,  and  will  be  destroyed  immediately  upon  project  completion.    Access  to  the  data  
entry  system  will  be  protected  by  username  and  password.  Username  and  password  will  be  delivered  
during  the  registration  process  for  individual  local  investigators.  All  electronic  data  transfer  between  
participating  centres  and  the  co-­‐ordinating  centre  will  be  username  and  password  protected.  Each  
centre  will  maintain  a  project  file  including  a  protocol,  local  investigator  delegation  log,  ethics  approval  
documentation  and  other  documents  as  appropriate.      
De-­‐identified  data  sent  via  HTTPS  (with  SSL)  to  the  server.  A  specific  SSL  certificate  will  be  
enabled  for  this  quality  improvement  project.    No  identifiable  patient  data  will  be  transmitted.    During  
the  registration  process,  system  prompts  to  investigators  name,  surname  and  the  CRN.  With  this  data,  
the  system  generates  a  key  (HASH)  random.    The  system  server  is  hosted  at  1and1  (Germany).  
 
3.9. Dataset  
A  realistic  data  set  will  be  fundamental  to  the  success  of  the  investigation.  We  have  identified  the  key  
data  points  whilst  not  discouraging  centres  from  participating  through  an  excessive  burden  of  data  
collection.  The  reliability  of  data  collection  will  be  analysed  formally  using  K-­‐statistics  or  intra-­‐class  
correlation  coefficients  as  appropriate.    
 

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3.10.

Statistical  analysis    

The  data  to  be  collected  are  all  collected  as  part  of  routine  clinical  care.  Categorical  variables  will  be  
described  as  proportions  and  will  be  compared  using  chi-­‐square  or  Fisher’s  exact  test.  Continuous  
variable  will  be  described  as  mean  and  standard  deviation  if  normally  distributed  or  median  and  inter-­‐
quartile  range  if  not  normally  distributed.  Comparisons  of  continuous  variables  will  be  performed  
using  one-­‐way  ANOVA  or  Mann-­‐Whitney  test  as  appropriate.  A  logistic  regression  model  will  be  
performed  to  assess  independent  association  between  prognostic  factors  and  outcomes.  Significance  
will  be  set  at  p<0.05.  A  single  final  analysis  is  planned  at  the  end  of  the  study.  
 
3.11.

Sample  size  analysis  

For  this  prospective  study  we  would  aim  to  enrol  as  many  patients  as  possible  within  the  24-­‐hour  
study  period.  
 
3.12.

Study  timeline  

Timeline  for  the  main  steps  of  the  study  are  described  below  


June  6th,  2013:  Identification  of  Steering  Committee  



June  6th,  2013:  Political  (ESICM  and  SCCM)  sign  off  of  study  



July  15,  2013:  Protocol  completion  



July  15th,  2013:  Finalization  of  CRF  variables  



July  15,  2013:  Commencement  of  eCRF  programming  



August,  2013:  Start  of  centre  recruitment  



November  7th,  2013:  Study  day  

 
3.13.

Organisation  

The  project  will  be  led  by  a  steering  committee  (TSC)  on  behalf  of  the  Surviving  Sepsis  Campaign.  The  
TSC  will  be  responsible  for  project  completion.  The  duties  of  this  team  will  include  administration  of  all  
project  tasks,  communication  between  project  partners  (including  funders,  steering  committee  
members,  national  and  local  co-­‐ordinators,  etc),  data  collation  and  management.  The  TSC  is  
responsible  for  the  scientific  conduct  and  consistency  of  the  project.  The  TSC  will  ensure  
communication  between  the  study  management  team  and  co-­‐ordinators  as  necessary.    
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3.14.

National  /  Local  co-­‐ordinators  

National  /  Local  co-­‐ordinators  will  be  appointed  by  the  TSC  to  lead  the  project  within  individual  
nations  and  to:  


Identify  local  co-­‐ordinators  in  participating  hospitals  



Assist  with  translation  of  project  paperwork  as  required  



Ensure  distribution  of  the  project  protocol,  eCRF  and  other  materials  



Ensure  necessary  regulatory  approvals  are  in  place  and  are  followed  prior  to  the  start  date    



Ensure  good  communication  with  the  participating  sites  in  his/her  nation  



Ensure  that  all  regulatory  paperwork  is  sent  to  TSC.  

 
3.15.

Local  co-­‐ordinators  

Local  co-­‐ordinators  in  individual  institutions  will  have  the  following  responsibilities:  


Provide  leadership  for  the  project  in  their  institution  



Ensure  all  relevant  regulatory  approvals  are  in  place  for  their  institution  



Ensure  adequate  training  of  all  relevant  staff  prior  to  data  collection  



Supervise  daily  data  collection  and  assist  with  problem  solving  



Act  as  guarantor  for  the  integrity  and  quality  of  data  collected  



Ensure  timely  completion  of  eCRFs  



Communicate  with  the  relevant  national  coordinator  

 
3.16.

Data  management  and  ownership  

On  behalf  of  the  TSC,  the  ESICM  will  act  as  custodian  of  the  data.  The  TSC  will  take  responsibility  for  
the  content  and  integrity  of  any  data.  
The  TSC  will  retain  the  right  to  use  all  pooled  data  for  scientific  and  other  purposes.  Only  summary  
data  will  be  presented  publicly.    
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3.17.

Publication  plan  

Data  will  be  presented  and  disseminated  in  a  timely  manner.  The  TSC  will  appoint  a  writing  committee  
to  draft  the  scientific  report(s)  of  this  project.  All  participating  centres  will  have  their  efforts  
recognized  by  the  lead  investigator  being  labelled  as  a  ‘collaborator’  in  the  authorship  of  the  paper  
and  thus  listed  in  PubMed.  
 
3.18.

Deliverables  

The  main  deliverables  will  be  scientific  reports  of  preliminary  findings  for  general  and  specialty  
journals  and  abstracts  for  presentation  to  national  and  international  meetings.  
 

 

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4. References  
1.  Angus  DC,  Linde-­‐Zwirble  WT,  Lidicker  J,  et  al:  Epidemiology  of  severe  sepsis  in  the  United  States:  
Analysis  of  incidence,  outcome,  and  associated  costs  of  care.  Crit  Care  Med.  2001;  29:1303–1310  
2.  Iwashyna  TJ,  Ely  EW,  Smith  DM,  et  al:  Long-­‐term  cognitive  impairment  and  disability  among  
survivors  of  severe  sepsis.  JAMA.  2010;304:1787-­‐1794    
3.  .Rubulotta  FM,  Ramsay  G,  Parker  MM,  et  al:    An  international  survey:  Public  awareness  and  
perception  of  sepsis  Crit  Care  Med.  2009  Jan;37:167-­‐70  
4.  Dellinger  RP,  Carlet  JM,  Masur  H,  et  al:  Surviving  Sepsis  Campaign  guidelines  for  management  of  
severe  sepsis  and  septic  shock.  Crit  Care  Med.  2004;  32:858–873  and  Intensive  Care  Med  2004;  
30:536–555  
5.    Dellinger  RP,  Levy  MM,  Carlet  JM,  et  al:  Surviving  Sepsis  Campaign:  International  guidelines  for  
management  of  severe  sepsis  and  septic  shock.  Crit  Care  Med.  2008;  36:296–327.  Erratum  in:  Crit  Care  
Med.  2008;  36:1394–1396  and  Intensive  Care  Med.  2008;  34:17–60  
6.    Dellinger  RP,  Levy  MM,  Rhodes  A,  et  al:  Surviving  Sepsis  Campaign:  International  guidelines  for  
management  of  severe  sepsis  and  septic  shock:  2012.  Crit  Care  Med.  2013;  41:  xxx-­‐xxx  and  Intensive  
Care  Med  2013;  39:  xxx-­‐xxx  
7.  Levy  MM,  Dellinger  RP,  Townsend  SR,  et  al;  Surviving  Sepsis  Campaign:  The  Surviving  Sepsis  
Campaign:  Results  of  an  international  guideline-­‐based  performance  improvement  program  targeting  
severe  sepsis.  Crit  Care  Med  2010;  38:367–374  
8.  Levy  MM,  Author  2,  Author  3,  et  al:    Title  of  paper.  2013;  in  preparation.  
9.  Levy  MM,  Artigas  A,  Phillips  GS,  et  al:    Outcomes  of  the  Surviving  Sepsis  Campaign  in  intensive  care  
units  in  the  USA  and  Europe:    a  prospective  cohort  study.  Lancet  Inf  Dis  2012;  12:919-­‐924  
10.  Rivers  E,  Nguyen  B,  Havstad  S,  et  al:  Early  goal-­‐directed  therapy  in  the  treatment  of  severe  sepsis  
and  septic  shock.  N  Engl  J  Med  2001;  345:1368–1377    
11.  Vincent  JL,  Sakr  Y,  Sprung  CL,  et  al.  Sepsis  in  European  intensive  care  units:  results  of  the  SOAP  
study.  Crit  Care  Med.  2006;34:344-­‐53.  
12.  Vincent  JL,  Rello  J,  Marshall  J,  et  al.  International  study  of  the  prevalence  and  outcomes  of  
infection  in  intensive  care  units.  JAMA.  2009;302:2323-­‐9.  

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