NCT00293592已完成不适用
Dexamethasone for Cardiac Surgery Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h)
研究概览
简要总结
This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery with the use of cardiopulmonary bypass. The primary endpoint is the occurrence of major complications (including all-cause mortality, myocardial infarction, stroke, renal failure, and prolonged mechanical ventilation) in the first 30 days after surgery.
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
- •All types of cardiac surgery in which cardiopulmonary bypass is used
排除标准
- •Age under 18 years
- •Life-expectancy < 6 months
- •Emergency operations
- •Re-operations within the same admission
研究组 & 干预措施
Dexamethasone
Active Comparator
干预措施: Dexamethasone (Drug)
Placebo
Placebo Comparator
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h)
时间窗: 30 days postoperatively
次要结局
未报告次要终点
研究者
D van Dijk
Anesthesiologist/Intensivist
UMC Utrecht
研究点 (1)
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