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

Table 2 Enrollment characteristics and data

	EGDT		ProCESS			ARISE		ProMISe
Treatment groups	EGDT	Control	EGDT	PBST	Usual	EGDT	Control	EGDT	Usual
Location	United States		United States			Multinational^a		United Kingdom
Number of centers	1		31			51^a		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

ISSN: 1364-8535