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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
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.
Seoul National University Hospital
Seoul, South Korea
28-day mortality
All cause mortality occurs within 28 days.
Time frame: 28 days
ICU length of stay
After 3 months from enrollment, the participant's ICU length of stay will be evaluated.
Time frame: 3 months
Mortality at hospital discharge
After 3 months from enrollment, the participant's in hospital mortality will be evaluated.
Time frame: 3 months
Development of the new infection
After 3 months from enrollment, the development of new infection of the participant during the hospitalization will be evaluated.
Time frame: 3 months
Serum selenium level
After study completion, serum selenium level will be measured from stored samples. Then, we will investigate whether selenium replacement contributes differently to the mortality reduction of the enrolled patients according to their initial serum selenium level.
Time frame: At 0, 24, 72, 168 hours post-enrollment
Ventilator days
After 3 months from enrollment, total numbers of ventilator days of the participant during the hospitalization will be evaluated.
Time frame: 3 months
Renal replacement therapy days
After 3 months from enrollment, the days of renal replacement therapy of the participant during the hospitalization will be evaluated.
Time frame: 3 months
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Oxidative stress marker
After study completion, serum glutathione peroxidase, reduced glutathione, NADPH, and MDA will be measured from stored samples.
Time frame: At 0, 24, 72, 168 hours post-enrollment
Changes in severity scores
APACHE II score, SOFA score, and SAPS II will be calculated at 1, 3, 7 days
Time frame: 7 days
3-month mortality
Time frame: 3 months post-enrollment
Inflammatory markers
After study completion, serum cytokines, CRP, and chemokines will be measured from stored samples.
Time frame: At 0, 24, 72, 268 hours post-enrollment
Vasopressor days
Days of dopamine, norepinephrine, dobutamine, vasopressin, and epinephrine will be investigated
Time frame: 3 months