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

December 30, 2015 updated by: wangqiang, Xijing Hospital

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

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.

Study Overview

Status

Unknown

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group

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.

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.
Other Names:
  • Edaravone Injection
Placebo Comparator: control group

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.

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

Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of DGF(postoperative complication after kidney transplantation)(%)
Time Frame: in the first week after the kidney transplantation
in the first week after the kidney transplantation
serum creatinine value (umoI/L)
Time Frame: within the first week
within the first week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Qiang Wang, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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