Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients
- Registration Number
- NCT02644915
- Lead Sponsor
- Xijing Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- ASA Ⅳ
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group 0.9%%NaCl solution 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. study group Edaravone 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.
- Primary Outcome Measures
Name Time Method Incidence of DGF(postoperative complication after kidney transplantation)（%） in the first week after the kidney transplantation serum creatinine value (umoI/L) within the first week
- Secondary Outcome Measures
Name Time Method 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