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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •clinical diagnosis of severe sepsis or septic shock
排除标准
- •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
研究组 & 干预措施
Selenium
500 mcg of selenium (10mL) daily for 7 days
干预措施: selenium replacement (Dietary Supplement)
Placebo
Placebo 10 mL (delivered from biosyn) for 7 days
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
28-day mortality
时间窗: 28 days
All cause mortality occurs within 28 days.
次要结局
- Ventilator days(3 months)
- Renal replacement therapy days(3 months)
- Serum selenium level(At 0, 24, 72, 168 hours post-enrollment)
- Oxidative stress marker(At 0, 24, 72, 168 hours post-enrollment)
- Inflammatory markers(At 0, 24, 72, 268 hours post-enrollment)
- Changes in severity scores(7 days)
- Development of the new infection(3 months)
- Vasopressor days(3 months)
- ICU length of stay(3 months)
- Mortality at hospital discharge(3 months)
- 3-month mortality(3 months post-enrollment)
研究者
Gil Joon Suh
Professor
Seoul National University Hospital