Table 2.
EGDT | ProCESS | ARISE | ProMISe | ||||||
---|---|---|---|---|---|---|---|---|---|
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 |
aNumber of study sites by country—Australia: 42 sites, New Zealand: 3 sites, Finland: 2 sites, Ireland: 1 site and Hong Kong: 3 sites
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