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. 2016 Mar 1;6(3):e008330. doi: 10.1136/bmjopen-2015-008330

Table 2.

The source of bias in terms of patient population and methodology of included trials

Rivers et al ProCESS, ARISE and ProMISe
Illness severity heterogeneity*
 Fluid challenge before enrolment 20 to 30 mL/kg 1000 mL
 Blood lactate levels at baseline, mmol/L 6.9 4.2–5.1
 APACHE II score at baseline 20.4 15.8–20.7
 ScvO2, at baseline, % 49.2 NR
 ScvO2, 0–6 h, % 66 75.9†
 Mechanical ventilation 0–6 h, % 53.8 19.0–22.4
 28-day mortality 49.2% 15.9–24.5%
Methodological differences
 CVC, %‡ 100 50.9–61.9
 Corticosteroid use None 8–37%
 Antibiotics treatment After enrolment Before enrolment
 Treatment in control group Well-defined Vague
 Blinding Double blinded Unblinded to the ICU clinicians
 Time of conduction 1997–2000 2008–2014 (EGDT recommendation in SSC Guidelines and the sepsis six)

*The data in control groups.

†The data in the EGDT group in ARISE.

‡The central venous catheterisation in control group: standard therapy in Rivers et al and usual care in the trio of trials.

CVC, central venous catheterisation; EGDT, early goal-directed therapy; NR, not reported; ScvO2, central venous oxygen saturation; SSC, Surviving Sepsis Campaign.