Randomized Clinical Trial to Evaluate the Use of Liraglutide in Individuals With Brain Death and Anti-inflammatory and Anti-apoptotic Effects on Organs to be Transplanted
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change inflammation
研究概览
简要总结
There is evidence of the association of brain death and inflammation, affecting outcomes of transplanted organs, but in a way not fully understood. Observational studies suggest that the use of target-guided therapies has a beneficial effect in reducing the rate of donor loss due to cardiac arrest and increasing the rate of donor-picked organs, which will be tested through the randomized clinical trial. However, no study so far has directly tested the effect of drugs with anti-inflammatory and anti-apoptotic properties administered to the donor in encephalic death in reducing inflammation of organs to be transplanted. This study aims to evaluate the use of liraglutide in patients with brain death in relation to their ability to attenuate the inflammation induced by encephalic death by means of a randomized clinical trial.
详细描述
The intervention group will be composed of individuals deceased in brain dead, after the conclusion of the brain dead protocol by the teams responsible for the Intensive care and will receive liraglutide. The control group will be composed of the same population of individuals who died in brain dead of the intervention group, but will receive a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •individuals deceased more than 18 years after the end of the brain death protocol
排除标准
- •Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide
研究组 & 干预措施
liraglutide
0,5ml
干预措施: Liraglutide (Drug)
结局指标
主要结局
change inflammation
时间窗: from 6 hours to 24 hours
change interleukin 6
次要结局
- change inflammation with liraglutide(from 6 to 24 hours)
- change inflammation liraglutide group(from 6 to 24 hours)
- change inflammation intervention group(from 6 to 24 hours)
- change inflammation(from 6 to 24 hours)
