drugset / Trial / NCT00207844

Selenium, as Sodium Selenite, in the Treatment of Septic Shock

NCT00207844 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

Septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit (ICU) care, where free radicals may play a key role, and a \>40% decrease in plasma selenium concentration is observed. Selenium is a trace element with both indirect enzymatic anti-oxidant, and direct oxidant properties. High dose of sodium selenite administration could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical pro-oxidative effect. We conduct a study to evaluate the effects of selenium treatment in comparison to placebo, in septic shock patients. Efficacy will be evaluated by the weaning time of catecholamines.

Timeline

Start
2002-01
Primary completion
—
Completion
2005-01

Outcome

Missed primary endpoint

paper The median time to vasopressor therapy withdrawal was 7 days in both groups (95% confidence interval = 5-8 and 6-9 PMID 17617901 ↗

paper respectively; log-rank, P = 0.713). PMID 17617901 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Selenium Other / unclassified 1000 ug Intravenous