Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Composite Outcome: independence from specific ICU procedures
研究概览
简要总结
This planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.
The aim of the present trial is to provide the scientific rationale for a large multicenter clinical trial, investigating the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery with prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a faster independency from life-sustaining technologies in the ICU and a decrease of postoperative morbidity and mortality. Before proceeding to the large-scale, definitive trial, the investigators propose to conduct a pilot study of the definitive randomized trial, to determine the feasibility of the study protocol.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Selenium Supplement (sodium selenite)
Active arm receiving Selenium in form of sodium selenite
干预措施: Selenium Supplement (sodium selenite) (Drug)
Placebo
Placebo arm receiving Sodium Chloride solution
干预措施: Placebo (Drug)
结局指标
主要结局
Composite Outcome: independence from specific ICU procedures
时间窗: postoperative day 28
As primary outcome, the investigators have chosen a composite outcome. This allows to assess the postoperative process of the included patients irrespective of extrinsic sources of irritation (e.g. daily routine, clinic based processes). The independency from specific ICU procedures is taken as a primary target (time is taken from postoperative admission to ICU after implantation of LVAD until the end of the characteristic ICU procedures): * mechanical ventilation * vasopressor therapy * mechanical circulatory support * renal replacement therapy
次要结局
- Incidence of nosocomial infections acquired at ICU(participants will be followed for the duration of hospital stay, an expected average of 5-10 days)
- Mechanical Ventilation(participants will be followed for the duration of hospital stay, an expected average of 5-10 days)
- Mortality(postoperative day 28)
- Persistent organ dysfunction(postoperative day 7)
- Acute renal failure(participants will be followed for the duration of hospital stay, an expected average of 5-10 days)
- postoperative delirium(participants will be followed for the duration of hospital stay, an expected average of 5-10 days)
- Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)(preoperative, by the end of surgery, on day 1, 3, 5, 7, 13, and if the patient is still in hospital, on day 28.)
- Quality of Life(postoperative day 28)