Sepsis, Shock, Septic
Conditions
Keywords
Sepsis, Shock, Septic, Selenium, Survival
Brief 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.
Interventions
DIETARY_SUPPLEMENTselenium 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_SUPPLEMENTPlacebo
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.
Sponsors
Biosyn
Boryung Pharmaceutical Co., Ltd
Gil Joon Suh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28 days | All cause mortality occurs within 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at hospital discharge | 3 months | After 3 months from enrollment, the participant's in hospital mortality will be evaluated. |
| Development of the new infection | 3 months | After 3 months from enrollment, the development of new infection of the participant during the hospitalization will be evaluated. |
| Serum selenium level | 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 | 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 | 3 months | After 3 months from enrollment, the days of renal replacement therapy of the participant during the hospitalization will be evaluated. |
| ICU length of stay | 3 months | After 3 months from enrollment, the participant's ICU length of stay will be evaluated. |
| Changes in severity scores | 7 days | APACHE II score, SOFA score, and SAPS II will be calculated at 1, 3, 7 days |
| 3-month mortality | 3 months post-enrollment | — |
| Inflammatory markers | At 0, 24, 72, 268 hours post-enrollment | After study completion, serum cytokines, CRP, and chemokines will be measured from stored samples. |
| Vasopressor days | 3 months | Days of dopamine, norepinephrine, dobutamine, vasopressin, and epinephrine will be investigated |
| Oxidative stress marker | 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. |
Countries
South Korea
Outcome results
None listed