Outcome of Living Donor Renal Transplantation in Assiut Urology and Nephrology University Hospital ,Initial Experience

November 7, 2017 updated by: Amr Mostafa Abdel Gawad, Assiut University

Assistant Lecturer of Urology in Assiut University

evaluation of outcome of living donor renal transplantation in assiut urology and nephrology university Hospital regarding the survival of patients and grafts , complications and quality of life after transplantation.

Study Overview

Status

Unknown

Conditions

Detailed Description

Renal failure is a widespread life threatening problem affecting a variety of age groups that needs a replacement therapy either regular dialysis with its drawbacks or kidney transplantation. Kidney transplantation is the treatment of choice for suitable candidates with ESRD. Since the advent of kidney transplantation in 1954, allograft and patient survival in the world have markedly improved because of advances in surgical techniques and immunosuppression. Few studies have compared kidney transplant outcomes In different countries. Because of varying allocation policies, cultural differences influencing preferences for living vs deceased donation, and government-funded health care in some countries, it is possible that post transplant outcomes are vastly different in other countries. Many studies described the current status of kidney allograft and patient survival in different countries based on data from the 2014 Scientific Registry of Transplant Recipients (SRTR) Annual Data Report. These outcomes are compared with those from Australia and New Zealand (ANZ), Europe, and Canada, using the most recent published registry data. A study was conducted showing that a total of 17,814 adult kidney transplants were performed in the United States in 2014. Of these, 12,279 were from deceased donors and 5535 were from living donors. Deceased donor allograft survival rates have improved over time. The most recent SRTR annual report showed long-term outcome data on recipients who underwent transplant from 1991 to 2014. From 2010 to 2014, the unadjusted 1-year allograft survival rate for recipients of a first deceased donor kidney transplant was 93.4% . For second or subsequent deceased donor transplants, the 1- year unadjusted allograft survival rate was comparable at 92.5%. It is well established that living donor kidney transplants are associated with superior post-transplant outcomes compared with deceased donor transplants, and this was reflected in the SRTR data. In recipients undergoing a primary living donor kidney transplant, the 1-year unadjusted allograft survival rate was 97.2%. In those undergoing retransplant from a living donor (first transplant from deceased or living donor), 1-year allograft survival was similar at 97.3%. Five-year unadjusted allograft survival rates for a first living donor kidney transplant and a second or subsequent transplant were 84.6% and 81.4%, respectively. Despite better outcomes, numbers of living donor transplants in the United States have decreased over the past 10 years; the largest decrease was in living-related donor kidney transplants, from 4340 in 2004 to 2693 in 2014.This underscores the ongoing need to encourage and support living donation. Potential explanations for the decline in living kidney donation include an aging U.S.A population such that potential donors are older, often have more comorbidity, and may not be medically suitable, financial disincentives, changes in organ allocation and donor selection criteria, and inadequate public awareness about the benefits of living organ donation.Although the recipient's health insurance covers the donor's donation related medical expenses, it does not reimburse for other expenses (eg, travel to the transplant center for predonation testing and surgery, lodging, lost wages during the post-surgery recovery period, especially for selfemployed or part-time workers, and higher premiums for health or life insurance or, difficulty obtaining it, after donation).The average out-of-pocket cost incurred by patients after living donation is reported to be $5000. In June 2014, the transplant community convened a Consensus Conference on Best Practices in Live Kidney Donation and issued several recommendations with the goal of making living donation financially neutral. Progress is being made as the Living Donor Protection Act was introduced in Congress in February 2016. A study showed that Patient Survival Recipients of living donor kidney transplants enjoy high survival rates, with little difference in outcomes for primary transplant and retransplant. The unadjusted 1-year patient survival rate was 97.0% for primary deceased donor transplant recipients from 2010 to 2014 and 97.2% for retransplant recipients. Patient survival at 5 years was 86.1% for first-transplant recipients and 88.9% for retransplant recipients who underwent deceased donor transplant from 2005 to 2009. For living donor transplant recipients, patient survival at 1 year and 5 years was 98.7% and 93.1% (primary transplant) and 99.0% and 92.9% (retransplant), respectively. This likely reflects selection bias during the evaluation for retransplant, when patients who were non adherent (perhaps leading to allograft failure) or who have substantial comorbidity are usually not deemed candidates for retransplant. Kidney transplant before dialysis initiation is associated with better post-transplant outcomes than transplant after dialysis initiation. another study reported that less than 6 months of pretransplant dialysis was associated with a 17% higher risk of death-censored allograft loss compared with preemptive transplant. The risk of allograft loss increased with longer pre -transplant dialysis time, although the relative increase after 3 years of dialysis was minimal. Similarly, this study showed that 6 months or longer of dialysis pretransplant was linked to a higher risk of death post-transplant compared with preemptive transplant. Other advantages of preemptive transplant include lower rates of delayed graft function and lower overall ESRD treatment costs compared with maintenance dialysis. In 2014, 17.1% of U.S.A adult transplant recipients underwent a pre emptive transplant. Although the proportion of preemptive living donor transplants increased from 23% in 1995 to 32% in 2014, growth has been stagnant since 2004 despite recognition of the benefits and new paradigms, such as the Kidney First Initiative. Previously, deceased donor kidneys were classified as standard criteria donor (SCD) or expanded criteria donor (ECD). A study showed that U.S.A has the highest 1-year survival rate for both primary and retransplant cases as compared to Australia ,Canada and Europe .while Australia has the highest 5-year survival rates .Canada and Europe have the lowest survival rates.

this study will be conducted on all recipient of living donor kidney transplantation in Assiut university urology &nephrology hospital to detect the outcome regarding survival rates of both grafts & patients, post-transplant quality of life and incidence of post -transplant complications.

Survival may be short term meaning that the graft will be functioning only for the 1st year while long term survival for more than 1st year, at any time if the patient returns to regular dialysis this means failure of the graft. Quality of life will be evaluated regarding physical performance, appearance, anxiety , frustration, depression and burden of immunosuppressants , comparison between post-transplant and pre- transplant status.

Complications of renal transplantation may be surgical or non surgical . Surgical complications may be urinary as (urinary leakage,urinary obstruction, urinoma ),lymphatic (lymphocele,lymphatic leakage and lymphatic obstruction)and vascular as ( renal artery stenosis , renal vein thrombosis,vascular aneurysms and rejection) . Non surgical as ( rejection, side effects of Immunosuppressants as viral infections,nephrotoxicity,skin changes,malignancy,etc) .

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 5715
        • Assiut University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

-All recipients of renal transplantation in Assiut urology and nephrology university Hospital

Description

Inclusion Criteria:

  • All recipients of renal transplantation in Assiut urology and nephrology university Hospital

Exclusion Criteria:

  • All recipients of renal transplantation who were transplanted outside Assiut urology and nephrology university Hospital

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life after renal transplantation
Time Frame: 2 years
Evaluation of physical and physological performance changes pre and post transplantation using kidney disease quality of life(KDQOL) score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Nasreldin Abdelall, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Renal Transplantation

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.

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