Triostat in Children During CardioPulmonary Bypass (CPB)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- duration of mechanical ventilation after cardiopulmonary bypass.
研究概览
简要总结
This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.
详细描述
Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. All patients undergo preoperative echocardiograms to provide preoperative cardiac function data. The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. This will be followed by iv for 12 hours. Operative data will be collected including CPB time, aortic cross-clamp time, length and degree of hypothermia. These data will be extracted from the anesthesia record.
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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Liothyronine Sodium/Triiodothyronine
bolus administration of Liothyronine Sodium/Triiodothyronine (Triostat) immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses, will be safe and will result in significant improvements in postoperative and clinical outcome parameters and cardiac contractile function.
干预措施: Liothyronine sodium/triiodothyronine (Drug)
Liothyronine Sodium/Triiodothyronine
bolus administration of Liothyronine Sodium/Triiodothyronine (Triostat) immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses, will be safe and will result in significant improvements in postoperative and clinical outcome parameters and cardiac contractile function.
干预措施: Cardiopulmonary bypass and cardiac surgery (Procedure)
Placebo
bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses
干预措施: Liothyronine sodium/triiodothyronine (Drug)
Placebo
bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses
干预措施: Cardiopulmonary bypass and cardiac surgery (Procedure)
结局指标
主要结局
duration of mechanical ventilation after cardiopulmonary bypass.
时间窗: 0 to 72 hours
Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.
次要结局
- Assess other parameters(0 to 72 hrs)
研究者
Michael Portman
Cardiologist
Seattle Children's Hospital