NCT01890317已完成不适用
Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
University of Leipzig2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cardiac Power Index after 24 hr.
研究概览
简要总结
Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction complicated by cardiongenic shock
- •Patients on mechanical ventilation at time of randomization
排除标准
- •Out of hospital resuscitation with indication for mild hypothermia
- •mechanical complications after acute myocardial infarction
- •duration of cardiogenic shock > 12 hours
- •age > 90 years
结局指标
主要结局
Cardiac Power Index after 24 hr.
时间窗: 24 hours
Cardiac Power Index after 24 hours as surrogate endpoint.
次要结局
- 30-days mortality(30 days)
- Length of mechanical ventilation(30 days)
- Catecholamine dose and duration of catecholamine support(30 days)
- Length of ICU-stay(30 days)
- SAPS-II-Score(96 hours)
- Sepsis(30 days)
- Stroke(30 days)
- Change of hemodynamics over the first 48 hr.(During first 48 hr)
- Severe and moderate bleeding complications (GUSTO-definition)(30 days)
- Pneumonia(30 days)
研究者
Holger Thiele
Co-Director Clinic for Internal Medicine/Cardiology
Heart Center Leipzig - University Hospital
研究点 (2)
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