Table 1.

Trials of Early Goal-directed Therapy

Study	Population	Intervention	A. Fluids from Presentation to Study Enrollment*	B. Fluids from Study Enrollment to Study Hour 6*†	C. Total Fluids from Presentation to Study Hour 6 (A + B)*	ScvO2 at Study Enrollment	Outcomes‡ (Intervention vs. Control)
Rivers et al. (7)	263 patients with septic shock in 1 U.S. emergency department	EGDT vs. usual care	N/A, prerandomization fluids were included in total reported fluids from Hours 0–6 (column B)	EGDT: 4,981 ml; standard therapy: 3,499 ml; (mean), P < 0.001	EGDT: 4,981 ml; standard therapy: 3,499 ml; (mean), P < 0.001	EGDT: 48.6% ± 11.2%; standard therapy: 49.2% ± 13.3%; (mean), P = 0.49	In-hospital mortality: 30.5% vs. 46.5%; P = 0.009
ARISE (8)	1,600 patients with septic shock in 51 hospitals in Australia and New Zealand	EGDT vs. usual care	EGDT: 2,515 ml; usual care: 2,591 ml; (mean), P value not reported	EGDT: 1,964 ml; usual care: 1,713 ml; (mean), P < 0.001	EGDT: 4,479 ml; usual care: 4,304 ml; (mean), P value not calculated	EGDT: 72.7% ± 10.5% (mean); ScvO2 was not monitored in the usual care group	90-d mortality: 18.6% vs. 18.8%; P = 0.90
ProCESS (9)	1,341 patients with septic shock in 31 U.S. hospitals	EGDT vs. protocol-based “standard” therapy vs. usual care	EDGT: 2,254 ml; protocol: 2,226 ml; usual care: 2,083 ml; (mean), P = 0.15	EGDT: 2,805 ml; protocol: 3,285 ml; usual care: 2,279 ml; (mean), P < 0.001	EDGT: 5,059 ml; protocol: 5,511 ml; usual care: 4,362 ml; (mean), P value not reported	Overall: 71% ± 13% (mean); ScvO2 was not routinely monitored in usual care group	60-d in-hospital mortality: 21.8% vs. 18.2% vs. 18.9%; P = 0.83
ProMISe (10)	1,260 patients with septic shock in 56 hospitals in England	EGDT vs. usual care	EDGT: 1,950 ml; usual care: 2,000 ml; (median), P value not reported	EGDT: 2,000 ml; usual care: 1,784 ml; (median), P value not reported	EDGT: 3,950 ml; usual care: 3,784 ml; (median), P value not reported	Overall: 70% ± 12% (mean); ScvO2 was not routinely monitored in usual care group	90-d mortality: 29.5% vs. 29.2%; P = 0.90; EGDT was associated with higher organ-failure scores, more days of cardiovascular support, and longer ICU stays

Definition of abbreviations: ARISE = Australasian Resuscitation in Sepsis Evaluation; EGDT = early goal-directed therapy; N/A = not applicable; ProCESS = Protocolized Care for Early Septic Shock; ProMISe = Protocolized Management in Sepsis; Scv_O2 = central venous oxygen saturation.

^*Rivers and colleagues (7) reported the total fluid patients received from presentation to Hour 6, whereas the ARISE, ProCESS, and ProMISe trials reported the fluid patients received before study enrollment and from study enrollment to Study Hour 6 separately, as denoted in columns A and B above. Column C is a summation of total fluid received before enrollment and during the first 6 hours of study enrollment in the ARISE, ProCESS, and ProMISe trials, to facilitate a comparison to the amount of fluid patients received in Rivers and colleagues.

^† Values do not include fluid received before randomization.

^‡ Listed as intervention versus usual care; P value.