NCT02320669已完成3 期
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Time To Extubation
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. Funding Source - FDA OOPD.
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
- — 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Male and female patients <5 months (152 days) of age
- •Patients undergoing cardiopulmonary bypass
排除标准
- •Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
- •Trisomy 13 and 18
- •Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
- •Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
- •Prior participation in the clinical trial
研究组 & 干预措施
Triostat
Experimental
Active Medication - Synthetic Thyroid Hormone
干预措施: Triostat (Drug)
Placebo
Placebo Comparator
Placebo Control
干预措施: Placebo (Drug)
结局指标
主要结局
Time To Extubation
时间窗: 30 days
time on mechanical ventilation after aortic cross clamp removal
次要结局
- ICU Length of Stay(30 days)
研究者
Michael Portman
Principal Investigator
Seattle Children's Hospital
研究点 (3)
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