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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
High-dose antithrombin III in the treatment of severe sepsis in patients with a high risk of death: Efficacy and safety
Critical Care Medicine, Volume 34, No. 2, Year 2006
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Description
Objective: To explore if patients with severe sepsis and with a predicted high risk of death (according to the Simplified Acute Physiology Score II) might have a treatment benefit from high-dose antithrombin III. Design: Subgroup analysis of a randomized, placebo-controlled, double-blind, prospective phase III study. Setting: Unifactorial and multifactorial reanalysis of prospectively defined populations from the KyberSept trial. Patients: We studied 1,008 patients (43.6% of the overall intention-to-treat population, n = 2,314) with a predicted mortality rate of 30-60% at study entry as defined by the Simplified Acute Physiology Score II. Interventions: Patients were randomized in a 1:1 fashion to receive either high-dose antithrombin III (30,000 IU intravenously over the period of 4 days) or placebo. Measurements and Main Results: In a Kaplan-Meier analysis of patients with a predicted mortality of 30-60%, the survival time when followed up for 90 days after admission was increased in the high-dose antithrombin III group compared with placebo (p = .04). If heparin was avoided during the 4-day treatment phase with high-dose antithrombin III (n = 140) or placebo (n = 162), the treatment effect appeared to be even more pronounced: 28-day mortality rate, 35.7% vs. 44.4% (risk ratio, 0.804; 95% confidence interval, 0.607-1.064); 56-day mortality rate, 39.9% vs. 52.2% (risk ratio, 0.764; 95% confidence interval, 0.593-0.984); 90-day mortality rate, 42.8% vs. 55.1% (risk ratio, 0.776; 95% confidence interval, 0.614-0.986). Like in the overall population, the percentage with any bleeding was increased in patients receiving high-dose antithrombin III compared with placebo. Survival rates were in favor of high-dose antithrombin III in patients both with and without bleeding complications. Conclusions: Treatment with high-dose antithrombin III may increase survival time up to 90 days in patients with severe sepsis and high risk of death. This benefit may even be stronger when concomitant heparin is avoided. Copyright © 2006 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.
Authors & Co-Authors
Wiedermann, C. J.
Italy, Bolzano
Central Hospital of the Province of Bolzano
United States, Vienna
Zlb Behring
Hoffmann, Johannes N.
Germany, Munich
Klinikum Der Universität München
Juers, Mathias
Germany, Marburg
Zlb Behring Gmbh
United States, Vienna
Zlb Behring
Ostermann, Helmut B.
Germany, Munich
Ludwig-maximilians-universität München
United States, Vienna
Zlb Behring
Kienast, Joachim
Germany, Munster
University of Münster
Briegel, Josef
Germany, Munich
Ludwig-maximilians-universität München
Strauss, Richard K.
Germany, Erlangen
Friedrich-alexander-universität Erlangen-nürnberg
United States, Vienna
Zlb Behring
Keinecke, Heinz Otto
Germany, Marburg
Covidence Gmbh
France, Gentilly
Sanofi S.a.
Warren, Brian Leigh
South Africa, Stellenbosch
Stellenbosch University
Opal, Steven M.
United States, Pawtucket
Memorial Hospital of Rhode Island
United States, Providence
The Warren Alpert Medical School
Statistics
Citations: 171
Authors: 10
Affiliations: 12
Identifiers
Doi:
10.1097/01.CCM.0000194731.08896.99
ISSN:
00903493
Research Areas
Disability
Health System And Policy
Study Design
Cross Sectional Study
Cohort Study
Quasi Experimental Study