Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Feasibility and safety
研究概览
简要总结
The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years;pronounced dead as per hospital brain-death criteria
- •Accepted by organ procurement organization for organ donation
- •Subjects within 3 hours of brain death pronouncement
排除标准
- •Consent cannot be obtained from authorized representative;mean arterial pressure < 60 mmHg and/ or more than 2 vasopressor and/or inotrope use
- •Presence of 2nd or 3rd degree heart block
- •Ongoing extracranial hemorrhage
- •International normalized ratio > 3.0
- •Donors with human-immunodeficiency virus infection
- •Pregnancy
研究组 & 干预措施
Hypothermia (32-33 degree C)
Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter
干预措施: Cold isotonic fluid and central venous hypothermia catheter (Other)
Normothermia (36.5 - 37.5 degree C)
Normothermia will be maintained until organ procurement as per current standard of care
结局指标
主要结局
Feasibility and safety
时间窗: From enrollment to organ procurement (average of 24 hours)
Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours
次要结局
- Malondialdehyde(Baseline, 6 hours, and at organ procurement (15-24 hrs))
- Actual no. of organs transplanted(At the time of organ procurement)
- Death receptor-5(Baseline, 6 hours, and at organ procurement (15-24 hrs))
- Six-month hospital free survival in recipients(6 months)
- Interleukin-6(Baseline, 6 hours, and at organ procurement (15-24 hrs))
- Urinary isoprostanes(Baseline, 6 hours, and at organ procurement (15-24 hrs))
- lactate(Baseline, 6 hours, and at organ procurement (15-24 hrs))
研究者
Raghavan Murugan
Associate Professor
University of Pittsburgh