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临床试验/NCT01479049
NCT01479049已完成不适用

The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery:a Randomized Controlled Trial

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
post-operative Serum cTnI concentration decreased significantly in 24hours

研究概览

简要总结

The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.

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 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • pediatric patients (body weight<10 kg)
  • congenital heart diseases and scheduled for a repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital.

排除标准

  • other systemic diseases

研究组 & 干预措施

MP group

Experimental

Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery.

干预措施: MP (moderate potassium) group (Drug)

HP group

Active Comparator

Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation

干预措施: HP (High potassium) group (Drug)

结局指标

主要结局

post-operative Serum cTnI concentration decreased significantly in 24hours

时间窗: 24h after myocardial reperfusion

myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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