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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Edaravone
* Drug: 0.9%%NaCl solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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. | Drug: Edaravone<br>* Edaravone 30mg dissolved in 0.9%NaCl 100ml 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.<br>* Other names: Edaravone Injection;|
| Placebo Comparator: control group<br>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. | Drug: 0.9%%NaCl solution<br>* 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<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average daily urinary volume（ml） |  | within the first week | 
| Hospital stays after operation(d) |  | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| graft survival |  | within 30 days after surgery | 
| other postoperative complication:acute rejection episodes、thrombosis、infections |  | within 30 days after surgery | 
| Content of Malondialdehyde（mol/m l）in the blood |  | before transplantation and 1, 2, 3 days after transplantation | 
| Content of Superoxide dismutase（U /m l) in the blood |  | before transplantation and 1, 2, 3 days after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia-reperfusion(I/R) injury, Edaravone