Table 2 Characteristics of available adult RCTs
| Â | 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 |