Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Incidence of DGF(postoperative complication after kidney transplantation)（%）
研究概览
简要总结
Ischemia-reperfusion (I/R) injury is a prominent cause of delayed graft function(DGF) after kidney transplantation. Reactive oxygen species play a crucial role in I/R injury. Edaravone is a synthetic radical scavenger that has been used in acute stroke. Some animal experiments have revealed its beneficial effects against I/R injury, our goal is therefore to investigate the effectiveness of a recipient pretreatment with Edaravone at reducing the occurrence of DGF after kidney transplantation.
详细描述
Participants will be randomly assigned, in a 1:1 ratio, to receive Edaravone or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Edaravone and 0.9 %NaCl solution will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes. The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded. The participation of each patient is scheduled for 1 month.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
- •Age 18yrs-55yrs for donors and the recipients
- •patients under hemodialysis
- •no other severe complications history for the donors and recipients
- •the first kidney transplant recipients
- •patients with written informed consent
排除标准
- •a second renal transplant,a multiorgan transplant or a dual kidney transplant
- •having severe comorbidity history,for example,severe cardiac dysfunction
- •cold ischemia time>24h or warm ischemia time>45min
- •variation of blood vessel ，operation time more than 2 hours
- •bleeding volume in operation>500ml and need for blood transfusion
- •participate in the other clinical trial 3 months before the enrollment
- •no suitable to participate in this experiment
研究组 & 干预措施
study group
Edaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes.
Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg.
干预措施: Edaravone (Drug)
control group
100ml 0.9%%NaCl solution,but without edaravone, will be treated at 10 minutes before kidney reperfusion, ending in 30 minutes.
Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg.
干预措施: 0.9%%NaCl solution (Drug)
结局指标
主要结局
Incidence of DGF(postoperative complication after kidney transplantation)（%）
时间窗: in the first week after the kidney transplantation
serum creatinine value (umoI/L)
时间窗: within the first week
次要结局
- Hospital stays after operation(d)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Content of Malondialdehyde（mol/m l）in the blood(before transplantation and 1, 2, 3 days after transplantation)
- average daily urinary volume（ml）(within the first week)
- other postoperative complication:acute rejection episodes、thrombosis、infections(within 30 days after surgery)
- graft survival(within 30 days after surgery)
- Content of Superoxide dismutase（U /m l) in the blood(before transplantation and 1, 2, 3 days after transplantation)
研究者
wangqiang
professor
Xijing Hospital