The Frequency and Risk Factors of Delayed Graft Function

NCT03555513 | Completed DMC

• 1 other identifier: SB24576H
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Delayed Graft Function; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• incidence of delayed graft function

  3 years

Secondary Outcomes (1)

• risk factors of DGF

  three years

Study Arms (1)

living kidney transplanted patients

Any patients over 18 who received kidney transplantation from living donor

Procedure: living kidney transplantation

Interventions

living kidney transplantation PROCEDURE

receiving kidney transplantation from living donor

living kidney transplanted patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Living donor kidney recipients with complete prior transplantation data and 3 years post transplantation follow up, including those who died during the observation period

You may not qualify if:

• kidney recipients younger than 18 years

Sponsors & Collaborators

• nooshin dalili: lead

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahid Beheshti University of Medical Sciences, Medical

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of SBMU

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share