NCT00791050Unknown不适用
To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap
Centro Cardiologico Monzino1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of atrial fibrillation
研究概览
简要总结
Although data on cardioprotective effects (as profile of troponin I)of perioperative maintenance of normothermia during CABGs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and the control group receiving standard institutional care.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated on pump CABGs
- •Age 18 - 85
- •Preoperative core temperature 36- 37.5 °C
排除标准
- •History of fever in the last week
- •Severe renal, hepatic,hematologic or pulmonary disease
- •Chronic Atrial fibrillation
- •History of acute MI in the last week
- •Previous neurologic abnormalities
结局指标
主要结局
Rate of atrial fibrillation
时间窗: First 48 postoperative hours
Rate of acute renal failure
时间窗: First 48 postoperative hours
次要结局
- Rate of Myocardial infarction and low output syndrome(First postoperative 48 hours)
- Rate of Type I neurological injury(First 48 postoperative hours)
- Total units of RBCs transfused(First 48 postoperative hours)
- Length of mechanical ventilation(First 48 postoperative hours)
- Rate of in-hospital mortality(30 postoperative days)
- Intensive Care Unit length of stay(30 postoperative days)
- Hospital length of stay(30 postoperative days)
- Cardiac Troponin I (cTnI) curve(First postoperative 24 hours)
研究者
研究点 (1)
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