Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Arrhythmia (yes/no)
研究概览
简要总结
Cardioplegic arrest is an essential part of cardiac surgery which aims to allow myocardial preservation and minimise myocardial swelling ,while providing a motionless and bloodless field ,.Blood cardioplegia has proven its efficacy for several decades and surgeons are still preferring to use it for myocardial protection of paediatric cardiac surgery ,although it is thought to be more time consuming since it is given with interrupted doses, . Even when advancement has came along the field of myocardial protection and cardioplegia solutions with the introduction of Bretschneider Histidine-Tryptophan-Ketoglutarate solution ,custodiol ,in 1970 ,which is given as a single dose and believed to be convenient, simple to deliver , and less time consuming . Many Surgeons haven't change their practice possibly due to paucity of studies comparing cardioplegia solutions in paediatric cardiac surgery and conflicting reports regarding the superiority of different cardioplegia solution.The investigators aim to provide evidence that will help paediatric cardiac surgeons to choose the optimal solution for their practice .
详细描述
Hypothesis :
Custodial is not inferior to blood cardioplegia in myocardial protection in paediatric cardiac surgery ..
Methodology :
Study design :
Randomized controlled trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding :
Surgeons will know the type of cardioplegia in the OR while other assessor will be blinded .
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All paediatric patients referred to our hospital which will undergo open cardiac repair with cardiopulmonary bypass and cardioplegic arrest .
排除标准
- •All emergency procedure( require immediate surgery)
- •Cases that don't require use of cardioplegia .
研究组 & 干预措施
blood cardioplegia group
patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
干预措施: Blood cardioplegia (Drug)
custodiol group
patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
干预措施: Custodiol Solution (Drug)
结局指标
主要结局
Arrhythmia (yes/no)
时间窗: up to 48 hours
post operative arrythmia that required intervention
Mortality (yes/no)
时间窗: up to 30 days
Death of all causes
ICU stay (days)
时间窗: up to 90 days (length of ICU stay required after the operative procedure recorded by days until discharge or death)
length of ICU stay
次要结局
- length of stay (days)(up to 90 days (length of the hospital stay required since admission recorded by days until discharge or death ))
- length of mechanical ventilation (hours)(up to 5 days)
- Subjective ventricular function (normal,mildly depressed ,moderately depressed ,moderately-severe depressed ,severly depressed )(up to 24 hours)
- Ejection fraction (percentage)(up to 24 hours)
- vasoactive inotropic score ( low or high)(up to 48 hour)
- myocardial biomarkers(up to 5 days)
- ECMO support (yes/no)(intraoperative)