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Table 2 Enrollment characteristics and data

From: Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE

Treatment groups EGDT Control EGDT PBST Usual EGDT Control EGDT Usual
Location United States United States Multinationala United Kingdom
Number of centers 1 31 51a 56
Setting Metropolitan academic teaching hospital Metropolitan academic teaching hospitals Metropolitan and rural tertiary and non-tertiary care teaching hospitals National Health Service hospitals throughout the United Kingdom
Enrollment time frame March 1997–March 2000 March 2008–May 2013 October 2008–April 2014 February 2011–July 2014
Duration of study (months) 36 62 66 41
Patients enrolled 263 1341 1600 1260
Eligible patients excluded 10.4 % 65.0 % 42.7 % 66.6 %
Enrollment/month/center 7 0.7 0.5 0.5
Lactate screening program For enrollment Required Required Required
Existing sepsis protocols No Yes (SSC and individual center protocols) Yes (SSC and national standards) Yes (SSC and national standards)
Fluid challenge 20–30 mL/kg Initially, 20 mL/kg; changed to 1000 mL (55 % enrolled using latter criteria) 1000 mL (70 % of patients) 1000 mL
Location of study ED ED/ICU ED/ICU ED/ICU
Blinding of ICU clinicians Yes No No No
Treatment team structure ED attending, resident, nurses (clinical care) Study physician/attending, study coordinator, nurse ED or ICU MD consultant, registrar, or nurse ED or ICU MD consultant, registrar, or nurse
Hours to randomization 1.3 1.5 3.3 3.1 3.0 2.8 2.7 2.5 2.5
ED length of stay (hours) 8.0 6.3 Not reported 1.4 2.0 1.2 1.2
  1. aNumber of study sites by country—Australia: 42 sites, New Zealand: 3 sites, Finland: 2 sites, Ireland: 1 site and Hong Kong: 3 sites
  2. ARISE Australasian Resuscitation in Sepsis Evaluation, ED emergency department, EGDT Early Goal-Directed Therapy, ICU intensive care unit, MD Medical Doctor, PBST protocol-based standard therapy, ProCESS Protocolized Care for Early Septic Shock, ProMISe Protocolized Management in Sepsis, SSC Surviving Sepsis Campaign