The Frequency and Risk Factors of Delayed Graft Function
June 1, 2018 updated by: nooshin dalili
The Frequency and Risk Factors of Delayed Graft Function in Living Donor Kidney Transplantation and Its Clinical Impact in Part of Middle East
Delayed graft function (DGF) is an important phenomenon after kidney transplantation with direct and indirect implication on graft survival.
Although its incidence and risk factors have been studied after cadaveric kidney transplantation cases, only few data is available regarding transplants from living donors.
The present study was performed to investigate the frequency and risk factors of DGF among living-unrelated kidney transplant recipients among three transplant centers in part of Middle East.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In this multi-center retrospective study, data from 480 transplanted patients had been collected from existing local hospital registries in three countries (Iran, Kingdom of Saudi Arabia (KSA), and Kuwait) with 3 years post transplantation follow-up.
Data for this study was collected based on routine clinical practice of medical practitioners across the participating countries.
A case report data collecting form was designed for gathering the data including the recipient and donor's characteristics prior to transplantation, and after transplantation up to three years post transplantation.
Using binary logistic regression analysis, the potential risk factors for occurrence of DGF in living donor transplantations were tested.
Graft and patient survival at 1, 2 and 3 years depending on follow-up time was evaluated.
Study Type
Observational
Enrollment (Actual)
500
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A case report data collecting form was designed for gathering the following data: the recipients and donors characteristics prior to transplantation, time on dialysis (months), first or second transplantation, panel reactive antibody (PRA) and human leukocyte antigen (HLA) mismatch, frequency of DGF, renal function, cold and warm ischemia time, immunosuppressive regimens (induction, if any used), adverse events, acute and chronic graft rejection, graft survival and patient survival at 1, 2 and 3 years follow-up.It was planned to recruit 500 patients, from 3 centers in 3 countries of Middle east.
Distribution by country or region was as following :Iran (n=300), Kuwait (n=100) and KSA (n=100) subjects .
As it was a retrospective disease registry with no access or possibility to recall patients, obtaining informed consent form from patients was waived up to the local regulatory processes.
Approvals were obtained from each site to access patients' records and collect their data.
Description
Inclusion Criteria:
Living donor kidney recipients with complete prior transplantation data and 3 years post transplantation follow up, including those who died during the observation period
Exclusion Criteria:
kidney recipients younger than 18 years
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
living kidney transplanted patients
Any patients over 18 who received kidney transplantation from living donor
|
receiving kidney transplantation from living donor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of delayed graft function
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
risk factors of DGF
Time Frame: three years
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shahid Beheshti University of Medical Sciences, Medical, Shahid Beheshti University of Medical Sciences
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 (Actual)
January 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
June 1, 2018
First Submitted That Met QC Criteria
June 1, 2018
First Posted (Actual)
June 13, 2018
Study Record Updates
Last Update Posted (Actual)
June 13, 2018
Last Update Submitted That Met QC Criteria
June 1, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SB24576H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.