Conditions: Sepsis
Keywords: Sepsis Septic shock
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1696
Healthy volunteers: no

Brief summary:
The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Drotrecogin alfa (activated) intervention 2: Placebo
Intervention descriptions: intervention 1: 24 microgram/kilogram/hour, intravenous, 96 hours (hr) intervention 2: 0.9% sodium chloride, intravenous, 96 hours

Protocol document: