NCT01338961已完成不适用
Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年4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
- 140
- 试验地点
- 2
- 主要终点
- Cardiac Troponin I release
研究概览
简要总结
Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated heart valve surgery
- •Heart valve surgery plus CABG
- •Age 20-80
排除标准
- •urgent operation
- •Left ventricle ejection fraction < 35%
- •Decompensated congestive heart failure
- •Chronic renal failure (glomerular filtration rate < 60 ml/min)
- •Severe hepatic and pulmonary disease
- •Bleeding diathesis or history of coagulopathy
- •Planed deep hypothermic circulatory arrest
- •History of acute myocardial infarction in the last 3 month
- •Preoperative core temperature >37oC
结局指标
主要结局
Cardiac Troponin I release
时间窗: 48 hours
次要结局
- Need for Inotropic Support(First 48 postoperative hours)
- Rate of Perioperative Myocardial Infarction(First 48 postoperative hours)
- Rate of Type I and Type II neurological injury(7 postoperative days)
- Rate of Dialysis-dependent acute renal failure(7 postoperative days)
- Rate of infectious complications(30 postoperative days)
- Total units of Red Blood Cells transfused(7 postoperative days)
- Intensive Care Unit length of stay(30 postoperative days)
- Hospital length of stay(30 postoperative days)
- Rate of In-hospital mortality(30 postoperative days)
- NT-proBNP release(First 24 postoperative hours)
- Bleeding from chest tubes(First 24 postoperative hours)
研究者
Efremov Sergey
Anesthesist
Meshalkin Research Institute of Pathology of Circulation
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)Ischemic Heart DiseaseValvular Heart DiseaseCardiovascular DiseasesSurgery-ComplicationsNCT05996120University of Leicester100
已完成
不适用
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve SurgeryHeart Valve DiseasesNCT01685554Northern State Medical University40
撤回
不适用
Ventilation During Cardiopulmonary Bypass (CPB) for Cardiac SurgeryPulmonary AtelectasisNCT02070445McMaster University
已完成
不适用
Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.RewarmingHypothermiaNCT03697122Duke University14
已完成
不适用
Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass VolumeHeart Valve DiseasesCoronary Artery DiseaseNCT01416792University of Saskatchewan61