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

• Conditions: Delayed Graft Function

• Registration Number: NCT02876692
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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 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 Timeline

• Study Start: 2016-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-09-01
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
delayed graft function	7 days after renal transplant
Transplant nephrectomy	1 year after reanl transplant

Secondary Outcome Measures

Name	Time	Method
Renal dysfunction caused by Surgical complications	within the first 3 months
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

Trial Locations

Locations (1)

First Affiliated Hospital Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China