NCT01548872Unknown4 期
Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- myocardial protective effect of HTK solution
研究概览
简要总结
The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective pediatric cardiac surgery
- •Patients written informed consent for study participation
排除标准
- •redo surgery
- •allergy to study drugs
- •unstable blood pressure before cardiac surgery
研究组 & 干预措施
crystalloid cardioplegia solution
Active Comparator
After aortic cross clamp 30ml/kg will be administered
干预措施: crystalloid cardioplegia solution (Drug)
HTK solution
Active Comparator
After aortic cross clamp 50ml/kg will be administered
干预措施: HTK solution (Drug)
结局指标
主要结局
myocardial protective effect of HTK solution
时间窗: postoperative 48 hours
to detect %33 difference in Troponin-I levels 4 hours postoperatively
次要结局
- hemodynamic and respiratory data(postoperative 48 hours)
研究者
Selim Kuslu
Anesthesiology Resident
Baskent University
研究点 (1)
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