Clinical trial NCT02876692: Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform
Official title: Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delayed Graft Function
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients assigned the deceased donor kidney to transplant in the waiting list.

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.

Eligibility criteria: 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

Primary outcomes:
measure: delayed graft function
timeFrame: 7 days after renal transplant
measure: Transplant nephrectomy
timeFrame: 1 year after reanl transplant
Secondary outcomes:
measure: Abnormal serum creatinine
timeFrame: Serum creatinine did not return to the normal range within the first 30 days
measure: Renal dysfunction caused by the acute rejection
timeFrame: within the first 3 months
measure: lung infection lead to death
timeFrame: within the first 1 year
measure: Renal dysfunction caused by Surgical complications
timeFrame: within the first 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: xiaoming D Ding, PhD
role: PRINCIPAL_INVESTIGATOR
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