NCT01398709Unknown2 期
Study of the Relationship Between Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.
详细描述
There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who had underwent cardiac surgery with cardiopulmonary bypass
排除标准
- •Preoperative liver or kidney disease or dysfunction
- •Preoperative coagulation disorder
- •Palliative operation or a second operation
- •Above 3 years
结局指标
主要结局
all cause mortality
时间窗: one year
次要结局
- Acute renal failure(one month)
- Respiratory failure(one month)
- ICU and hospital length of stay, and ICU readmissions(one month)
- Stroke and reversible ischemic neurologic deficit(one month)
- Measures of inflammation(one month)
- Biochemical markers of myocardial necrosis(one month)
- Perioperative complications(one month)
研究者
研究点 (1)
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