Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Delayed graft function
研究概览
简要总结
The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult recipients older than 18 years;
- •Patients diagnosed with end-stage renal diseases and volunteered to register in the Transplant and Dialysis Registry of China awaiting for deceased donor kidney transplantation;
- •First single kidney transplantation;
- •The recipients can understand the purpose and risk of deceased kidney transplantation and sign informed consent;
- •Ethics committee approved.
排除标准
- •Patients less than 18 years old, or more than 65 years old;
- •Patients who receive multiple organ transplants;
- •Diagnosed with malignancy or had a history of malignancy in the past 5 years;
- •non-kidney transplantation history.
结局指标
主要结局
Delayed graft function
时间窗: Within one week posttransplantation
Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation.
次要结局
- Graft loss(One year after transplantation)
- biopsy-confirmed acute rejection(One year after transplantation)
研究者
Tao Lin
Deputy Director of the Organ Transplant Center
West China Hospital