Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients

Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial

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.

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.

Inclusion Criteria:

1. ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease
2. Age 18yrs-55yrs for donors and the recipients
3. patients under hemodialysis
4. no other severe complications history for the donors and recipients
5. the first kidney transplant recipients
6. patients with written informed consent

Exclusion Criteria:

1. ASA Ⅳ
2. a second renal transplant,a multiorgan transplant or a dual kidney transplant
3. having severe comorbidity history,for example,severe cardiac dysfunction
4. cold ischemia time>24h or warm ischemia time>45min
5. variation of blood vessel ，operation time more than 2 hours
6. bleeding volume in operation>500ml and need for blood transfusion
7. participate in the other clinical trial 3 months before the enrollment
8. no suitable to participate in this experiment