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

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ClinicalTrials.gov Identifier: NCT02644915
Recruitment Status : Unknown
Verified December 2015 by wangqiang, Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
First Affiliated Hospital Xi'an Jiaotong University
Information provided by (Responsible Party):
wangqiang, Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Edaravone Drug: 0.9%%NaCl solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : March 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Edaravone

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.

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.
Other Name: 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.

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

Other Name: normal saline




Primary Outcome Measures :
  1. Incidence of DGF(postoperative complication after kidney transplantation)(%) [ Time Frame: in the first week after the kidney transplantation ]
  2. serum creatinine value (umoI/L) [ Time Frame: within the first week ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644915


Contacts
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Contact: Xiao-ying Zhao 13513616985 zhaoxy06@163.com
Contact: Qiang Wang 86-29-84775343 wangqiang@fmmu.edu.cn

Sponsors and Collaborators
Xijing Hospital
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: Qiang Wang Xijing Hospital
Publications:
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Responsible Party: wangqiang, professor, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02644915    
Other Study ID Numbers: zxy
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by wangqiang, Xijing Hospital:
ischemia-reperfusion(I/R) injury
Edaravone
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs