SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial). A Multicentre Randomized Controlled Trial of High Dose Sodium-selenite Administration in High Risk Cardiac Surgical Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,400
- 试验地点
- 23
- 主要终点
- PODS free days + alive
研究概览
简要总结
The aim of the investigators' research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a fewer complications, less organ injury and fewer deaths. Before the investigators conducted the large definitive trial, they conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot patients into the definitive trial.
详细描述
Over a million patients undergo open heart surgery annually and this number is likely to accelerate as the population ages and the prevalence of diabetes and cardiovascular disease continue to increase. Unfortunately, death, organ failure, and other serious complications are all too frequent following open heart surgery, especially in some high-risk patient populations.
Selenium is a trace element that is important for many of the body's regulatory and metabolic functions especially during times of stress. International members of the study team have shown in a non-randomized study that high dose selenium supplementation was associated with improved clinical outcomes compared to a historical control group. The next step in this program of research is to conduct a randomized trial.
The aim of this research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to fewer complications, less organ injury and fewer deaths.
The investigators propose to conduct a randomized, placebo-controlled, double-blind, multicentre definitive trial of 1400 patients across 20 sites in Germany and Canada, which will include the pilot study patients. An industry partner (Biosyn) will provide the product and some additional support for the European sites. Patients will be randomized to receive either a daily perioperative high-dose selenium or placebo until postoperative day 10 (maximum) or upon earlier discharge from ICU. If the hypothesis is proven true, and this simple, inexpensive nutrient reduces complications and improves recovery of patients undergoing cardiac surgery, there is the potential to dramatically change clinical practice and improve health outcomes.
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
- •Adult patients (>/=18 years of age)
- •Scheduled to undergo elective or urgent cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest that exhibit a high perioperative risk profile as defined by the presence of one or more of the following:
- •a) Planned valve surgery combined with CABG or multiple valve replacement/repair surgeries or combined cardiac surgical procedures involving the thoracic aorta; OR
- •b) Any cardiac surgery with a high perioperative risk profile, defined as a predicted operative mortality of ≥ 5% (EuroSCORE II).
排除标准
- •We will exclude patients who meet any of the following criteria:
- •Isolated procedures (CABG only or valve)
- •Known hypersensitivity to sodium-selenite or to any of the constituents of the solution.
- •Renal failure requiring dialysis at the point of screening.
- •Chronic liver disease as evidenced by a pre-operative total bilirubin >2 mg/dl or 34 umol/L.
- •Disabling neuropsychiatric disorders (severe dementia, severe Alzheimer's disease, advanced Parkinson's disease).
- •Pregnancy or lactation period.
- •Simultaneous participation in another clinical trial of an experimental therapy (co-enrolment acceptable in observational studies or randomized trials of existing therapies if permitted by both steering committees and local ethics boards).
- •Patients undergoing heart transplantation or preoperative planned LVAD insertion or complex congenital heart surgery.
- •Alternate contacts of investigators (required by German Regulatory Authorities).
研究组 & 干预措施
Placebo
Normal saline will be administered to subjects intravenously pre-operatively, upon admission to the ICU, then daily up to post-operative day 10 or ICU discharge, whichever occurs first.
干预措施: Placebo (Drug)
sodium selenite
High-dose sodium-selenite will be administered to subjects intravenously:
- pre-operatively (2000 ug); 2) upon admission to the ICU (2000 ug), 3) then daily (1000 ug) up to post-operative day 10 or ICU discharge, whichever occurs first.
干预措施: sodium selenite (Drug)
结局指标
主要结局
PODS free days + alive
时间窗: 30 Day
Evaluate the PODS free days + alive as the primary outcome for the large-scale Phase III trial. We define PODS as the need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or intermittent hemodialysis).
次要结局
- 30-Day Mortality(30 Day)
- Hospital Acquired Infections(30 day)
- Duration of Mechanical Ventilation(6-months)
- Quality of Life(6-months)
- 6-minute walking test(up to 3 months)
- Perioperative hemodynamic profile(6 months)
- Cardiovascular Complications(6-months)
- ICU Length of stay(6-months)
- 6-Month Survival(6-months)
- Return to work(6-months)
- Incidence of post-operative delirium(6-months)
- Hospital Re-admission Rates(6-months)
- Hospital Length of stay(6-months)
研究者
Daren K. Heyland
Scientific Director
Clinical Evaluation Research Unit at Kingston General Hospital