Intermittent Anti-grade Portal and Graft Purge Ameliorates Post-reperfusion Syndrome in Living Donor Liver Transplantation Recipients. A Prospective, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Post-reperfusion syndrome
研究概览
简要总结
Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.
详细描述
Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •living donor liver transplantation recipients
排除标准
- 未提供
结局指标
主要结局
Post-reperfusion syndrome
时间窗: 5 minutes after portal declamping
Reduced Mean arterial blood pressure to the predefined value
次要结局
- Severity of post-reperfusion syndrome(5 minutes after portal declamping)
- One month patient mortality(one month post-operative)
- Graft ischemia reperfusion injury(one week post-operative)
研究者
Amr Mohamed Yassen
Professor of Anesthesia and Intensive Care
Mansoura University