Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients (SEREAL)
|ClinicalTrials.gov Identifier: NCT01601938|
Recruitment Status : Withdrawn (We failed to obtain study drugs from the company)
First Posted : May 18, 2012
Last Update Posted : March 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Shock, Septic||Dietary Supplement: selenium replacement Dietary Supplement: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||May 2014|
500 mcg of selenium (10mL) daily for 7 days
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.
Other Name: Selenase T pro injectione
Placebo Comparator: Placebo
Placebo 10 mL (delivered from biosyn) 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.
Other Name: Normal saline
- 28-day mortality [ Time Frame: 28 days ]All cause mortality occurs within 28 days.
- ICU length of stay [ Time Frame: 3 months ]After 3 months from enrollment, the participant's ICU length of stay will be evaluated.
- Mortality at hospital discharge [ Time Frame: 3 months ]After 3 months from enrollment, the participant's in hospital mortality will be evaluated.
- Development of the new infection [ Time Frame: 3 months ]After 3 months from enrollment, the development of new infection of the participant during the hospitalization will be evaluated.
- Serum selenium level [ Time Frame: At 0, 24, 72, 168 hours post-enrollment ]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.
- Ventilator days [ Time Frame: 3 months ]After 3 months from enrollment, total numbers of ventilator days of the participant during the hospitalization will be evaluated.
- Renal replacement therapy days [ Time Frame: 3 months ]After 3 months from enrollment, the days of renal replacement therapy of the participant during the hospitalization will be evaluated.
- Oxidative stress marker [ Time Frame: At 0, 24, 72, 168 hours post-enrollment ]After study completion, serum glutathione peroxidase, reduced glutathione, NADPH, and MDA will be measured from stored samples.
- Changes in severity scores [ Time Frame: 7 days ]APACHE II score, SOFA score, and SAPS II will be calculated at 1, 3, 7 days
- 3-month mortality [ Time Frame: 3 months post-enrollment ]
- Inflammatory markers [ Time Frame: At 0, 24, 72, 268 hours post-enrollment ]After study completion, serum cytokines, CRP, and chemokines will be measured from stored samples.
- Vasopressor days [ Time Frame: 3 months ]Days of dopamine, norepinephrine, dobutamine, vasopressin, and epinephrine will be investigated
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601938
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Gil Joon Suh, professor||Seoul National University Hospital|