NCT02876692

Brief Summary

This is a prospective cohort study:

  1. 1.First step: to establish a new scoring system for predication of delayed graft function(DGF) following kidney transplantation based on previous and new study data. The new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and kidney evaluation System based on Lifeport platform ).
  2. 2.Second step: validate the new scoring system through prospective cohort study in our transplantation center and modify the scoring system if needed. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft survival and patient survival
  3. 3.Step 3: Further validate the new scoring system in six other transplantation centers and developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF, AR, graft survival and patient survival

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

August 19, 2016

Last Update Submit

August 30, 2016

Conditions

Delayed Graft Function

Outcome Measures

Primary Outcomes (2)

  • delayed graft function

    7 days after renal transplant

  • Transplant nephrectomy

    1 year after reanl transplant

Secondary Outcomes (4)

  • Abnormal serum creatinine

    Serum creatinine did not return to the normal range within the first 30 days

  • Renal dysfunction caused by the acute rejection

    within the first 3 months

  • lung infection lead to death

    within the first 1 year

  • Renal dysfunction caused by Surgical complications

    within the first 3 months

Interventions

Machine perfusionDEVICE

Deceased donor kidneys were preserved by hypothermic machine perfusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients assigned the deceased donor kidney to transplant in the waiting list.

You may qualify if:

  • Donor
  • \. Comply with the national donation after citizen death guideline
  • \. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
  • \. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
  • \. No activity of untreated systemic bacterial, viral or fungal infection;
  • \. Patients definitely identified
  • Recipient:
  • \. 65 y old ≥Age\> = 18 years old, male or female
  • \. BMI\<26
  • \. Renal transplantation first time
  • \. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
  • \. Before the clinical trial, Patient sign informed consent voluntarily

You may not qualify if:

  • Donor
  • \. Older than 65 years old
  • Serum hepatitis B virus (HBV), hepatitis C virus (HCV), HIV positive
  • Donor kidney cold storage time over 30 hours
  • Warm ischemia time over 20 minutes
  • Other reagents are added perfusion for regulation of donor renal function
  • Recipient:
  • Involved in other study.
  • Double organ or multi-organ transplant
  • A,B,O blood type-incompatible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (15)

  • Allen AM, Kim WR, Xiong H, Liu J, Stock PG, Lake JR, Chinnakotla S, Snyder JJ, Israni AK, Kasiske BL. Survival of recipients of livers from donation after circulatory death who are relisted and undergo retransplant for graft failure. Am J Transplant. 2014 May;14(5):1120-8. doi: 10.1111/ajt.12700. Epub 2014 Apr 14.

    PMID: 24731165BACKGROUND

  • Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. A pilot programme of organ donation after cardiac death in China. Lancet. 2012 Mar 3;379(9818):862-5. doi: 10.1016/S0140-6736(11)61086-6. Epub 2011 Nov 10.

    PMID: 22078722BACKGROUND

  • Huang J, Wang H, Fan ST, Zhao B, Zhang Z, Hao L, Huo F, Liu Y. The national program for deceased organ donation in China. Transplantation. 2013 Jul 15;96(1):5-9. doi: 10.1097/TP.0b013e3182985491.

    PMID: 23743728BACKGROUND

  • World Health Organization. WHO guiding principles on human cell, tissue and organ transplantation. Transplantation. 2010 Aug 15;90(3):229-33. doi: 10.1097/TP.0b013e3181ec29f0. No abstract available.

    PMID: 20664493BACKGROUND

  • Moers C, Leuvenink HG, Ploeg RJ. Non-heart beating organ donation: overview and future perspectives. Transpl Int. 2007 Jul;20(7):567-75. doi: 10.1111/j.1432-2277.2007.00455.x. Epub 2007 Jan 30.

    PMID: 17263786BACKGROUND

  • Kokkinos C, Antcliffe D, Nanidis T, Darzi AW, Tekkis P, Papalois V. Outcome of kidney transplantation from nonheart-beating versus heart-beating cadaveric donors. Transplantation. 2007 May 15;83(9):1193-9. doi: 10.1097/01.tp.0000261710.53848.51.

    PMID: 17496535BACKGROUND

  • Jochmans I, Darius T, Kuypers D, Monbaliu D, Goffin E, Mourad M, Ledinh H, Weekers L, Peeters P, Randon C, Bosmans JL, Roeyen G, Abramowicz D, Hoang AD, De Pauw L, Rahmel A, Squifflet JP, Pirenne J. Kidney donation after circulatory death in a country with a high number of brain dead donors: 10-year experience in Belgium. Transpl Int. 2012 Aug;25(8):857-66. doi: 10.1111/j.1432-2277.2012.01510.x. Epub 2012 Jun 13.

    PMID: 22694305BACKGROUND

  • Chamorro C, Falcon JA, Michelena JC. Controversial points in organ donor management. Transplant Proc. 2009 Oct;41(8):3473-5. doi: 10.1016/j.transproceed.2009.09.004.

    PMID: 19857774BACKGROUND

  • Gelb AW, Robertson KM. Anaesthetic management of the brain dead for organ donation. Can J Anaesth. 1990 Oct;37(7):806-12. doi: 10.1007/BF03006543.

    PMID: 2225301BACKGROUND

  • Xue W, Tian P, Ding X, Pan X, Yan H, Hou J, Feng X, Xiang H, Tian X, Ren L, Zheng J, Li S. Clinical research and social status investigation for donor and recipient of living-related kidney transplant. Int Urol Nephrol. 2013 Feb;45(1):239-49. doi: 10.1007/s11255-012-0259-0. Epub 2012 Aug 15.

    PMID: 22893495RESULT

  • Wadei HM, Heckman MG, Rawal B, Taner CB, Farahat W, Nur L, Mai ML, Prendergast M, Gonwa TA. Comparison of kidney function between donation after cardiac death and donation after brain death kidney transplantation. Transplantation. 2013 Aug 15;96(3):274-81. doi: 10.1097/TP.0b013e31829807d1.

    PMID: 23778649RESULT

  • Singh RP, Farney AC, Rogers J, Zuckerman J, Reeves-Daniel A, Hartmann E, Iskandar S, Adams P, Stratta RJ. Kidney transplantation from donation after cardiac death donors: lack of impact of delayed graft function on post-transplant outcomes. Clin Transplant. 2011 Mar-Apr;25(2):255-64. doi: 10.1111/j.1399-0012.2010.01241.x.

    PMID: 20331689RESULT

  • Mallon DH, Summers DM, Bradley JA, Pettigrew GJ. Defining delayed graft function after renal transplantation: simplest is best. Transplantation. 2013 Nov 27;96(10):885-9. doi: 10.1097/TP.0b013e3182a19348.

    PMID: 24056620RESULT

  • Nagaraja P, Roberts GW, Stephens M, Horvath S, Fialova J, Chavez R, Asderakis A, Kaposztas Z. Influence of delayed graft function and acute rejection on outcomes after kidney transplantation from donors after cardiac death. Transplantation. 2012 Dec 27;94(12):1218-23. doi: 10.1097/TP.0b013e3182708e30.

    PMID: 23154212RESULT

  • Lodhi SA, Lamb KE, Uddin I, Meier-Kriesche HU. Pulsatile pump decreases risk of delayed graft function in kidneys donated after cardiac death. Am J Transplant. 2012 Oct;12(10):2774-80. doi: 10.1111/j.1600-6143.2012.04179.x. Epub 2012 Jul 23.

    PMID: 22823748RESULT

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • xiaoming D Ding, PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenguang D Ding, PhD

CONTACT

8602985323721doctor_ding@126.com

Xiaoming D Ding, PhD

CONTACT

8602985323721xmding@mail.xju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of renal transplant department

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 24, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)