A Randomized Clinical Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-Reperfusion Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Renal graft and recipients survival
研究概览
简要总结
To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury.
All registered eligible candidates for kidney transplant will be randomized to receive either:
- retrograde venous, then arterial reperfusion or
- antegrade arterial reperfusion.
详细描述
According to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury.
For the study Chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group.
The study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. Only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.The main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion).
Patients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. After the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. Then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. Retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. Further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed.
Patients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion.
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
- Single (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
- •patients with end-stage kidney disease who are ready for kidney transplantation;
- •Panel reactive antibodies (PRA) less than 20%.
- •informed consent to participate in the study.
排除标准
- •recipients preparing for combined organ transplantation;
- •recipients with previously performed transplantation of another organ;
- •recipients preparing for transplantation with a different immunosuppressive regimen;
- •upcoming blood group incompatibility (AB0-i) transplant;
- •PRA antibodies more than 20%;
结局指标
主要结局
Renal graft and recipients survival
时间窗: 3 months
Renal graft function quality and recipients survival
次要结局
- Median serum creatinine levels(1 months)
- Median serum urea levels(1 months)
- Median glomerular filtration rate (GFR) levels(1 month)
研究者
Myltykbay Rysmakhanov
PhD-doctoral, Department of Surgery No 2, MD
West Kazakhstan Medical University