Table 2

Characteristics of available adult RCTs

PROWESS [13]

ADDRESS [14]


Inclusion criteria summary

Severe sepsis ≥ 1 organ dysfunction*

Severe sepsis ≥ 1 organ dysfunction* and low risk of death

Therapy initiation

within 48 hours of first organ dysfunction

Within 48 hours of first organ dysfunction

Active treatment

96 hour intravenous infusion of drotrecogin alfa (24 μg/kg/hr)

96 hour intravenous infusion of drotrecogin alfa (24 μg/kg/hr)

Placebo

96-hour intravenous infusion (0.9% NaCl)

96-hour intravenous infusion (0.9% NaCl)


Baseline characteristics

Drotrecogin alfa

Placebo

Drotrecogin alfa

Placebo

N

N = 850

N = 840

N = 1333

N = 1307

Age, mean ± SD (years)

60.5 ± 17.2

60.6 ± 16.5

58.8 ± 16.8

58.6 ± 16.7

Male (%)

56.1%

58%

56.3%

58.5%

APACHE II score, mean ± SD

24.6 ± 7.6

25 ± 7.8

18.2 ± 5.8

18.2 ± 5.9

Mechanical ventilation (%)

73.3%

77.6%

56.3%

55.8%

Shock (%)

70.4%

71.7%

NA

NA

Use of any vasopressor (%)

71.8%

75.5%

47.9%

47.5%

≥ 2 organ dysfunctions (%)

74.6%

75.8%

34.5%

31.5%

Time from 1st organ dysfunction to study drug start (hours), mean ± SD

17.5 ± 12.8

17.4 ± 9.1

22.5 ± 13.6

22.6 ± 13.8


* Cardiovascular, renal, respiratory, hematologic, or unexplained metabolic acidosis

RCT = randomized controlled trial/SD = standard deviation

Costa and Brophy BMC Anesthesiology 2007 7:5   doi:10.1186/1471-2253-7-5

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