NCT01601938

Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients

Effects of Selenium Replacement on Prognosis of Severe Sepsis and Septic Shock Patients and Their Initial Serum Selenium Level: a Randomized, Double-blind Placebo Controlled Phase 2 Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gil Joon Suh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sepsis
• Shock, Septic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	selenium replacement	Selenium 500 mcg (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
DIETARY_SUPPLEMENT	Placebo	placebo (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2012-05-18
• Last updated: 2016-03-04

Locations

1 site across 1 country: South Korea