Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death
- Abraham, Edward
- Laterre, Pierre-François
- Garg, R
- Levy, H
- Talwar, D
- Trzaskoma, Benjamin
- Francois, B.
- Guy, JS
- Bruckmann, M
- Rea-Neto, A
- Rossaint, R
- Perrotin, D
- Sablotzki, A
- Arkins, N
- Utterback, Barbara
- Macias, WL
DOIAbstract
BACKGROUND: In November 2001, the Food and Drug Administration (FDA) approved drotrecogin alfa (activated) (DrotAA) for adults who had severe sepsis and a high risk of death. The FDA required a study to evaluate the efficacy of DrotAA for adults who had severe sepsis and a low risk of death. METHODS: We randomly assigned adult patients with severe sepsis and a low risk of death (defined by an Acute Physiology and Chronic Health Evaluation [APACHE II] score <25 or single-organ failure) to receive an intravenous infusion of placebo or DrotAA (24 microg per kilogram of body weight per hour) for 96 hours in a double-blind, placebo-controlled, multicenter trial. The prospectively defined primary end point was death from any cause and was assesse...
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