NCT02211053终止4 期
Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Study feasibility
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior signed written informed from family member (no more needed following amendment in July 2016)
- •16 years of age or older
- •Brain death diagnosis
- •Left ventricular ejection fraction < 50% determined by transthoracic echocardiography or hemodynamic instability defined as a mean dose of noradrenaline 0.1 mcg/kg/min + vasopressin
排除标准
- •Heart failure history (removed after june 2015)
- •Chronic exogenous oral T4 or T3 before death (removed after june 2015)
- •Having received T4 infusion before recruitment(removed after june 2015)
- •Echographic images not interpretable
- •Age 75 and older(removed after june 2015)
- •Prior coronary heart disease defined as prior coronary artery bypass graft or percutaneous coronary intervention (with or without stents)(removed after june 2015)
研究组 & 干预措施
Levothyroxine
Active Comparator
Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion
干预措施: Levothyroxine (Drug)
Placebo
Placebo Comparator
Infusion matched to intervention arm
干预措施: placebo (Drug)
结局指标
主要结局
Study feasibility
时间窗: In 2 years
1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation
Variation in left ventricular ejection fraction
时间窗: 6 hours post infusion
次要结局
- Numbers of donated hearts(On organ donation surgery)
- Incidence of de novo atrial fibrillation(From beginning of infusion until beginning of retrieval surgery)
- Time from recruitment to the administration of the study drug(From randomization to 12 hours post randomization)
研究者
Anne Julie Frenette
Intensive Care Pharmacist, Associate Clinical Professor
Hopital du Sacre-Coeur de Montreal
研究点 (1)
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