跳至主要内容
临床试验/NCT00293592
NCT00293592已完成不适用

Dexamethasone for Cardiac Surgery Trial

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2006年5月最近更新:
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

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

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

D van Dijk

Anesthesiologist/Intensivist

UMC Utrecht

研究点 (1)

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