Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform (Xi'anCri)

August 30, 2016 updated by: Ding Xiaoming, First Affiliated Hospital Xi'an Jiaotong University

This is a prospective cohort study:

  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. 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. 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjects are enrolled to collect the data of donors and recipients. Investigators also collect the data of recipients or donated organs as following: physiological and biochemical indexes, machine perfusion parameters, and the other factors effected on renal transplant outcomes. A Cox proportional hazards model and multiple linear regression analysis will be applied to examine the correlation among the univariate and multivariate. Based on the above analysis to improve the new scoring system, Lifeport work platform evaluation system and donor kidney quality evaluation system. Then, a multi-center clinical trial will be started to improve and verify the new scoring system. Finally, a donor kidney evaluation APP will be developed based on the scoring system and the database of clinical trials. An applicaiotion (APP) will be popularized the national transplant surgeons.

Study Type

Observational

Enrollment (Anticipated)

1000

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

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital Xi'an Jiaotong University
        • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

Donor

  • 1. Comply with the national donation after citizen death guideline
  • 2. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
  • 3. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
  • 4. No activity of untreated systemic bacterial, viral or fungal infection;
  • 5. Patients definitely identified

Recipient:

  • 1. 65 y old ≥Age> = 18 years old, male or female
  • 2. BMI<26
  • 3. Renal transplantation first time
  • 4. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
  • 5. Before the clinical trial, Patient sign informed consent voluntarily

Exclusion Criteria:

Donor

  • 1. Older than 65 years old
  • 2.Serum hepatitis B virus (HBV), hepatitis C virus (HCV), HIV positive
  • 3.Donor kidney cold storage time over 30 hours
  • 4.Warm ischemia time over 20 minutes
  • 5.Other reagents are added perfusion for regulation of donor renal function

Recipient:

  • 1.Involved in other study.
  • 2.Double organ or multi-organ transplant
  • 3.A,B,O blood type-incompatible

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
delayed graft function
Time Frame: 7 days after renal transplant
7 days after renal transplant
Transplant nephrectomy
Time Frame: 1 year after reanl transplant
1 year after reanl transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Abnormal serum creatinine
Time Frame: Serum creatinine did not return to the normal range within the first 30 days
Serum creatinine did not return to the normal range within the first 30 days
Renal dysfunction caused by the acute rejection
Time Frame: within the first 3 months
within the first 3 months
lung infection lead to death
Time Frame: within the first 1 year
within the first 1 year
Renal dysfunction caused by Surgical complications
Time Frame: within the first 3 months
within the first 3 months

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: xiaoming D Ding, PhD, First Affiliated Hospital Xi'an Jiaotong University

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.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XAC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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