NCT02644915

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

December 10, 2015

Last Update Submit

December 30, 2015

Conditions

Kidney Transplantation

Keywords

ischemia-reperfusion(I/R) injuryEdaravone

Outcome Measures

Primary Outcomes (2)

  • Incidence of DGF(postoperative complication after kidney transplantation)（%）

    in the first week after the kidney transplantation

  • serum creatinine value (umoI/L)

    within the first week

Secondary Outcomes (6)

  • average daily urinary volume（ml）

    within the first week

  • Hospital stays after operation(d)

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • graft survival

    within 30 days after surgery

  • other postoperative complication:acute rejection episodes、thrombosis、infections

    within 30 days after surgery

  • Content of Malondialdehyde（mol/m l）in the blood

    before transplantation and 1, 2, 3 days after transplantation

  • +1 more secondary outcomes

Study Arms (2)

study group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

EdaravoneDRUG

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.

Also known as: Edaravone Injection
study group
0.9%%NaCl solutionDRUG

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

Also known as: normal saline
control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 22386035BACKGROUND

  • 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.

    PMID: 19100411BACKGROUND

  • 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.

    PMID: 16412242BACKGROUND

  • 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.

    PMID: 8996759BACKGROUND

  • 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.

    PMID: 9112349BACKGROUND

  • 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.

    PMID: 15541456BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

EdaravoneSaline Solution

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Qiang Wang

    Xijing Hospital

    STUDY CHAIR

Central Study Contacts

Xiao-ying Zhao

CONTACT

13513616985zhaoxy06@163.com

Qiang Wang

CONTACT

86-29-84775343wangqiang@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 10, 2015

First Posted

January 1, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

January 1, 2016

Record last verified: 2015-12