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临床试验/NCT02540447
NCT02540447已完成不适用

Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure

研究概览

简要总结

The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.

详细描述

All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program

排除标准

  • •re-transplantation
  • •Previous upper abdominal operation
  • •Budd Chiari syndrome

研究组 & 干预措施

Purge

Experimental

The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.

干预措施: Purge (Procedure)

No Purge

No Intervention

The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.

结局指标

主要结局

Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure

时间窗: 5 minutes post-reperfusion

The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping

次要结局

  • Post-operative Infectious Complications(30 days)
  • Biliary Complications (Participants)(3 months)
  • Ischemia Reperfusion Injury(7 days)
  • 3 Months Mortality(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Mohamed Yassen

Professor of Anesthesia and Intensive Care

Mansoura University

研究点 (1)

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