Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Heart failure necessitating inotropic drug administering after heart valve surgery
研究概览
简要总结
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.
Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.
详细描述
200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Eligible for cardiac valve or combined CABG and cardiac valve surgery:
- •Clinical signs of cardiac insufficiency
排除标准
- •Endocarditis
研究组 & 干预措施
1
Levosimendan
干预措施: levosimendan (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
Heart failure necessitating inotropic drug administering after heart valve surgery
时间窗: Postoperative hospital period
次要结局
- Hospital morbidity and mortality(Postoperative hospital period)
- Postoperative mortality at six months(Six months postoperatively)