Randomized Clinical Trial: Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- • Vasoactive-Inotropic Score
研究概览
简要总结
Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare HTK cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of Fallot planned for total repair.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with tetralogy of Fallot spectrum.
- •Sex (males and females)
- •Age 6 months- 5 years.
排除标准
- •Persistent left SVC draining in the coronary sinus.
- •Mental or neurologic disorders.
- •Preoperative critically ill patients.
- •Parents or legal guardian refusal.
- •Fallot repair with transannular patch( as it will affect on the RV function as a single agent after reperfusion)
研究组 & 干预措施
Group A (HTK cardioplegia)
will receive HTK cardioplegia in volume 30 ml/Kg given by antegrade route through an aortic route cannula.
干预措施: HTK cardioplegia (Drug)
Group B ( Cold Cardioplegia)
will receive group cold Blood Cardioplegia in volume 20mL/kg given by antegrade route through an aortic route cannula and repeated 10mL/kg/dose every 25minutes at 8-12°C for maintenance. This technique considered the standard management in this age.
干预措施: Cold Cadioplegia (Drug)
结局指标
主要结局
• Vasoactive-Inotropic Score
时间窗: From time of separation of cardioplumonary bypass till 24 hours post operative
Calculate the doses of vasoactive drugs used
次要结局
未报告次要终点
研究者
samar mohammed
Lecturer of Anesthesia
Ain Shams University