NCT01221116终止不适用
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2003年1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
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Need for inotropic agents or IABP (intra aortal balloon pump)
研究概览
简要总结
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
详细描述
Single center, prospective, randomized parallel-group, double-blinded study
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EF (ejection fraction)<40%
排除标准
- •renal failure, liver failure
研究组 & 干预措施
1: Type of surgery
No Intervention
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
干预措施: levosimendan (Drug)
结局指标
主要结局
Need for inotropic agents or IABP (intra aortal balloon pump)
时间窗: jan 2003 - dec 2008
次要结局
- Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.(jan 2003-dec 2008)
研究者
研究点 (1)
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