NCT02644915

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Edaravone	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.
DRUG	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

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-01-01
• Last updated: 2016-01-01