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

Primary Purpose

Kidney Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Edaravone
0.9%%NaCl solution
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Transplantation focused on measuring ischemia-reperfusion(I/R) injury, Edaravone

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    study group

    control group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of DGF(postoperative complication after kidney transplantation)（%）
    serum creatinine value (umoI/L)

    Secondary Outcome Measures

    average daily urinary volume（ml）
    Hospital stays after operation(d)
    graft survival
    other postoperative complication:acute rejection episodes、thrombosis、infections
    Content of Malondialdehyde（mol/m l）in the blood
    Content of Superoxide dismutase（U /m l) in the blood

    Full Information

    First Posted
    December 10, 2015
    Last Updated
    December 30, 2015
    Sponsor
    Xijing Hospital
    Collaborators
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02644915
    Brief Title
    Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients
    Acronym
    I/R
    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

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xijing Hospital
    Collaborators
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Transplantation
    Keywords
    ischemia-reperfusion(I/R) injury, Edaravone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Edaravone
    Other Intervention Name(s)
    Edaravone Injection
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    0.9%%NaCl solution
    Other Intervention Name(s)
    normal saline
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Incidence of DGF(postoperative complication after kidney transplantation)（%）
    Time Frame
    in the first week after the kidney transplantation
    Title
    serum creatinine value (umoI/L)
    Time Frame
    within the first week
    Secondary Outcome Measure Information:
    Title
    average daily urinary volume（ml）
    Time Frame
    within the first week
    Title
    Hospital stays after operation(d)
    Time Frame
    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
    Title
    graft survival
    Time Frame
    within 30 days after surgery
    Title
    other postoperative complication:acute rejection episodes、thrombosis、infections
    Time Frame
    within 30 days after surgery
    Title
    Content of Malondialdehyde（mol/m l）in the blood
    Time Frame
    before transplantation and 1, 2, 3 days after transplantation
    Title
    Content of Superoxide dismutase（U /m l) in the blood
    Time Frame
    before transplantation and 1, 2, 3 days after transplantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASAⅡ-Ⅲ,elective operation patients with end-stage renal disease Age 18yrs-55yrs for donors and the recipients patients under hemodialysis no other severe complications history for the donors and recipients the first kidney transplant recipients patients with written informed consent Exclusion Criteria: ASA Ⅳ a second renal transplant,a multiorgan transplant or a dual kidney transplant having severe comorbidity history,for example,severe cardiac dysfunction cold ischemia time>24h or warm ischemia time>45min variation of blood vessel ，operation time more than 2 hours bleeding volume in operation>500ml and need for blood transfusion participate in the other clinical trial 3 months before the enrollment no suitable to participate in this experiment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiao-ying Zhao
    Phone
    13513616985
    Email
    zhaoxy06@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qiang Wang
    Phone
    86-29-84775343
    Email
    wangqiang@fmmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qiang Wang
    Organizational Affiliation
    Xijing Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22386035
    Citation
    Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6. Erratum In: Lancet. 2012 Aug 18;380(9842):650.
    Results Reference
    background
    PubMed Identifier
    19100411
    Citation
    Shah VR, Butala BP, Parikh GP, Vora KS, Parikh BK, Modi MP, Bhosale GP, Mehta T. Combined epidural and general anesthesia for paediatric renal transplantation-a single center experience. Transplant Proc. 2008 Dec;40(10):3451-4. doi: 10.1016/j.transproceed.2008.06.065.
    Results Reference
    background
    PubMed Identifier
    16412242
    Citation
    Kontodimopoulos N, Niakas D. Overcoming inherent problems of preference-based techniques for measuring health benefits: an empirical study in the context of kidney transplantation. BMC Health Serv Res. 2006 Jan 14;6:3. doi: 10.1186/1472-6963-6-3.
    Results Reference
    background
    PubMed Identifier
    8996759
    Citation
    Ibrahim S, Jacobs F, Zukin Y, Enriquez D, Holt D, Baldwin W 3rd, Sanfilippo F, Ratner LE. Immunohistochemical manifestations of unilateral kidney ischemia. Clin Transplant. 1996 Dec;10(6 Pt 2):646-52.
    Results Reference
    background
    PubMed Identifier
    9112349
    Citation
    Ojo AO, Wolfe RA, Held PJ, Port FK, Schmouder RL. Delayed graft function: risk factors and implications for renal allograft survival. Transplantation. 1997 Apr 15;63(7):968-74. doi: 10.1097/00007890-199704150-00011.
    Results Reference
    background
    PubMed Identifier
    15541456
    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.
    Results Reference
    background

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

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