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Clinical Trial Summary

This study will be performed to determine whether selenium replacement reduces 28-day mortality of severe sepsis and septic shock patients, and to investigate whether selenium replacement contributes differently to the mortality reduction of the patients according to their initial serum selenium level.


Clinical Trial Description

This study is a single center, randomized, double-blind, placebo controlled trial.

After the diagnosis of severe sepsis and septic shock, enrolled patients will be randomized. Then, selenium or placebo will be intravenously administered to them for 7 days. Hemodynamic and laboratory data will be recorded for 7 days and additional serum samples will be obtained at 0, 24, 72, and 168 hours post-treatment and stored. Mortality will be observed for 28 days.

An interim analysis will be conducted by the independent data safety monitoring board.

Serum selenium levels will be measured from the stored serum samples after the study completion. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01601938
Study type Interventional
Source Seoul National University Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date September 2012
Completion date May 2014

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