Clinical Trial: Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform

Brief Summary:

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

Detailed Summary: 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.
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current Primary Outcome:

  • delayed graft function [ Time Frame: 7 days after renal transplant ]
  • Transplant nephrectomy [ Time Frame: 1 year after reanl transplant ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Abnormal serum creatinine [ Time Frame: 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 ]
  • lung infection lead to death [ Time Frame: within the first 1 year ]
  • Renal dysfunction caused by Surgical complications [ Time Frame: within the first 3 months ]


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: August 19, 2016
Date Started: January 2016
Date Completion: December 2019
Last Updated: August 30, 2016
Last Verified: August 2016