Pediatric Myocardial Protection; Large Volume Potassium Cardioplegia Advantageous Over Small Volume Potassium Cardioplegia: Where do we Stand?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Cardiac rhythm on return
研究概览
简要总结
The advances in cardiac surgery and anesthesia for pediatric patients planned for repair of congenital heart disease encourage us to discuss problems that occur during this surgery especially during Cardiopulmonary Bypass (CPB). Cardiopulmonary Bypass induces a damaging systemic inflammatory response, in addition to a myocardial ischemia-reperfusion injury (IRI) as a result of cessation and re-initiation of coronary artery circulation
详细描述
After approval of the local ethics committee of Assiut University and obtaining written informed consent from parents or guardians of all patients, 60 patients with congenital heart disease will be included. Patients will be randomly allocated into three groups
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previous cardiac surgery.
- •Urgent or emergent cases.
- •Any known allergies to components of either cardioplegia solutions.
研究组 & 干预措施
Group L
Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg The content of cardioplegic solution will be (K+, 10mmol/L) lidocaine 50 mg/L, magnesium sulphate 1 gm/L,dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery. Cardioplegic infusion duration will be infused over 300s.
干预措施: Cold blood cardioplegia (large volume) (Drug)
Group S
Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg The content of cardioplegic solution will be (K+, 30mmol/L) lidocaine 150 mg/L, magnesium sulphate 3 gm/L, dextrose 25% 25 mL/L and sodium bicarbonate 8.4% 25 mL/L during cardiac surgery.
干预措施: Cold blood cardioplegia (small volume) (Drug)
结局指标
主要结局
Cardiac rhythm on return
时间窗: within the first 24 hours
Sinus rhythm or Ventricular Fibrillation: DC will be used or not and if used how much joules and how many times.
次要结局
- The inotropic score(within one month)
- Cardiac dysrhythmias(within the first week)
- blood pressure(within the first 24 hours)
- transthoracic echocardiography (TTE) changes(within the first week)
- Troponin I levels(within the first 24 hours)
研究者
Sayed Kaoud Abd-Elshafy
Associate Profossor of Anesthesiology
Assiut University