Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Composite outcome of liver function following liver transplantation.
研究概览
简要总结
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility
排除标准
- •haemodynamic instability that precludes safe administration of 2% sevoflurane.
研究组 & 干预措施
Sevoflurane
1 MAC of sevoflurane for 15 minutes before organs procurement.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Composite outcome of liver function following liver transplantation.
时间窗: First week post-transplantation
* Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days. * Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by : * bilirubin ≥10 mg/dL on the 7th day. * INR ≥ 1.6 on the 7th day. * ALAT or ASAT \> 2000 UI/L during the first 7 postoperative days.
次要结局
- • Incidence of primary non function (liver failure requiring emergent re-transplantation)(30-day and 6-month after transplantation.)
- • Allograft function (yes/no) at 30-day and 6-month after transplantation.(30-day and 6-month after transplantation.)
- • Hospital length of stay.(30-day and 6-month after transplantation.)
- • Hospital mortality and at 30-day.(30-day.)
研究者
Gregory Minguet
Doctor
University of Liege