Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Outcome Measure: all cause mortality
研究概览
简要总结
Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.
详细描述
Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. New progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. But the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. Our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as cTnI. This study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with CPB and cardioplegia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia
- •Body weight less than or equals to 10kg
排除标准
- •Cardiac surgery is performed without cardiopulmonary or cardioplegia
- •Body weight more than 10Kg
研究组 & 干预措施
adenosine
Adenosine will be administered intravenously before surgery
干预措施: adenosine (Drug)
结局指标
主要结局
Outcome Measure: all cause mortality
时间窗: within the first 30 days (plus or minus 3 days) after surgery
次要结局
- The time of ICU stay(within the first 30 days (plus or minus 3 days) after surgery)