Effect of Parenteral Alpha-Tocopherol in the Definitive Surgery of Tetralogy of Fallot
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum Troponin I Concentration (ng/L)
研究概览
简要总结
Introduction:
Tetralogy of Fallot (ToF) correction with cardiopulmonary bypass (CPB) poses a risk of ischemia-reperfusion injury, especially in cyanotic myocardium. Alpha-tocopherol, a potent antioxidant, may reduce myocardial damage during surgery.
Methods:
This randomized controlled trial included 58 ToF patients aged 1-10 years undergoing definitive surgery with CPB at Integrated Heart Center, Cipto Mangunkusumo Hospital. Patients were randomly assigned to receive either parenteral alpha-tocopherol (4 mg/kg) or placebo at the initiation of CPB. The primary outcome was postoperative troponin I level.
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 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital heart disease Tetralogy of Fallot (ToF)
- •Age between 1 and 10 years
- •Scheduled for definitive repair of ToF using cardiopulmonary bypass (CPB) at PJT-RSCM
排除标准
- •History of prior palliative surgery (e.g., Blalock-Taussig shunt)
- •Presence of additional congenital heart disease requiring major modification or addition of surgical procedures
- •History of central nervous system disorder or stroke
- •History of cardiopulmonary resuscitation (CPR)
- •Undergoing redo surgery (e.g., residual stenosis, bleeding)
研究组 & 干预措施
alpha-tocopherol
assigned to receive either parenteral alpha-tocopherol (4 mg/kg)
干预措施: alpha-Tocopherol (Drug)
sterile water for injection
the control group received a placebo (sterile water for injection/aquabidest)
干预措施: Sterile Water for Injection (Drug)
结局指标
主要结局
Change in Serum Troponin I Concentration (ng/L)
时间窗: Before surgery, 1 hour after surgery, and 8 hours after surgery
Serum Troponin I concentration will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to assess the extent of myocardial injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair.
次要结局
- Change in Serum Malondialdehyde (MDA) Concentration (ng/mL)(Before surgery, 1 hour after surgery, and 8 hours after surgery)
- Change in Serum Lactate Concentration (mmol/L)(Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery)
- Myocardial Injury Score (Histopathology, Scale 0-3)(15 minutes after release of the aortic cross-clamp)
- Apoptotic Index (% of Apoptotic Cardiomyocytes)(tissue sample is collected 15 minutes after releasing the aortic cross clamp)
- Duration of Mechanical Ventilation (hours)(From end of surgery until extubation)
- anti-cTnI(tissue sample is collected 15 minutes after releasing the aortic cross clamp)
- GPx expression(tissue sample is collected 15 minutes after releasing the aortic cross clamp)
- Intensive Care Unit Length of Stay (days)(From ICU admission until ICU discharge, assessed up to 14 days)
- Hospital Length of Stay (days)(From hospital admission until hospital discharge, assessed up to 30 days)
- Vasoactive-Inotropic Score (VIS, Scale 0-X)(First 24 hours after surgery)
研究者
Suprayitno Wardoyo
Consultant Cardiothoracic Surgeon
Dr Cipto Mangunkusumo General Hospital