Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients (SEREAL)

Gil Joon Suh

Status and phase

Withdrawn

Phase 2

Conditions

Shock, Septic

Sepsis

Treatments

Dietary Supplement: Placebo

Dietary Supplement: selenium replacement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01601938

SNUHEM-SEREAL-12-0001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 18 or older
clinical diagnosis of severe sepsis or septic shock

Exclusion criteria

pregnancy or breast feeding
age younger than 18
advanced directive state to withhold treatment
known allergy to selenium
CPR or death within 24 hours after the diagnosis of severe sepsis or septic shock
advanced malignancy without further treatment plan