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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Kidney Transplantation

Treatments: Drug: Edaravone; Drug: 0.9%%NaCl solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02644915

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

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.

Treatment:

Drug: Edaravone

control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9%%NaCl solution