CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed
Drug / intervention
Selenium as sodium selenitedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00207844
NCT00207844Phase 2Completed

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of a Therapeutic Administration of Selenium, as Selenite, in Septic Shock Patients.

Centre Hospitalier de Meaux·interventional·Posted Sep 21, 2005·Updated Sep 21, 2005

In Brief

A Phase 2 clinical trial evaluating Selenium as sodium selenite for Septic Shock and Severe Sepsis. Completed, across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartJan 1, 2002
Study CompletionJan 1, 2005
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Selenium as sodium selenitedrug