The Frequency and Risk Factors of Delayed Graft Function

Kidney Transplant; Complications Clinical Trial

Official title:

The Frequency and Risk Factors of Delayed Graft Function in Living Donor Kidney Transplantation and Its Clinical Impact in Part of Middle East

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555513
• Other study ID #: SB24576H
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: June 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Graft Function
• Kidney Transplant; Complications

Intervention

Procedure:
• living kidney transplantation
receiving kidney transplantation from living donor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
nooshin dalili

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delayed graft function		3 years
Secondary	risk factors of DGF		three years