Clinical trial NCT02644915: Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients
Official title: Effect of Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients: A Single-Center, Double-Blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Keywords: ischemia-reperfusion(I/R) injury
Edaravone
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital Xi'an Jiaotong University
First posted: 2016-01-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of DGF(postoperative complication after kidney transplantation)（%）
timeFrame: in the first week after the kidney transplantation
measure: serum creatinine value (umoI/L)
timeFrame: within the first week
Secondary outcomes:
measure: average daily urinary volume（ml）
timeFrame: within the first week
measure: Hospital stays after operation(d)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: graft survival
timeFrame: within 30 days after surgery
measure: other postoperative complication:acute rejection episodes、thrombosis、infections
timeFrame: within 30 days after surgery
measure: Content of Malondialdehyde（mol/m l）in the blood
timeFrame: before transplantation and 1, 2, 3 days after transplantation
measure: Content of Superoxide dismutase（U /m l) in the blood
timeFrame: before transplantation and 1, 2, 3 days after transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Qiang Wang
role: STUDY_CHAIR
References:
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citation: Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.