Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- DGF
研究概览
简要总结
Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).
详细描述
The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.
- •ECD is defined as followed: deceased donors > 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension
排除标准
- •Recipients of living donor kidney transplants
- •Previous kidney transplantation
- •Participation in other kidney related trials
- •The subject received an investigational drug within 30 days prior to inclusion
- •The subject is unwilling or unable to follow the procedures outlined in the protocol
- •The subject is mentally or legally incapacitated
- •Non-German or non-English speakers
- •Family members of the investigators or employees of the participating department
- •The subject is mentally or legally incapacitated
- •The subject suffers from uncontrolled bacterial or viral infection
结局指标
主要结局
DGF
时间窗: 7 days post-transplant
DGF (defined as the need for dialysis in the first 7-days post-transplantation)
次要结局
- Perfusion Parameter(During HOPE)
- Renal function(Subjects will be followed 6 months postoperatively)
- postoperative complications(Subjects will be followed 6 months postoperatively)
- CRR2, CRR5(5 days post-transplant)
- Cumulative postoperative complications(Subjects will be followed 6 months postoperatively)
- Duration of intensive care stay(Subjects will be followed 6 months postoperatively)
- Duration of hospital stay(Subjects will be followed 6 months postoperatively)
- Graft survival(Subjects will be followed 6 months postoperatively)
研究者
Georg Lurje, M.D.
Attending Transplant Surgeon
University Hospital, Aachen