Effects of Graft Vascular Dimensions on Surgical and Functional Outcomes of Living Donor Kidney Transplantation

April 2, 2023 updated by: Mohamed Loay, Assiut University

Effects of Graft Vascular Dimensions on Perioperative Surgical and Functional Outcomes of Living Donor Kidney Transplantation in Pediatrics and Adults: A Prospective Case Series

  1. Correlate the radiological and intraoperative measuring of the vascular dimensions,
  2. Assess the effect of the vascular dimensions on the short-term surgical complications and
  3. Assess the effect of the vascular dimensions on the primary graft function in pediatric and adults KTs.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Vascular complications after kidney transplantation (KT) are variably rare with an incidence of 3-15%. They are a significant and most serious part of surgical complications of KT. They may acutely result in graft loss during surgery or early in the perioperative period and may threaten patient's life. The most common forms of early vascular complications are haemorrhage, hematomas, arterial or venous thrombosis, arterial vasospasm, and arterial intimal dissection. In pediatric and adult KT, most studies addressing the vascular complications followed a common attitude of estimating the prevalence and management of these complications rather than studying the predisposing factors. Specifically, studying the normal and abnormal anatomy of the grafts has mainly been directed towards the number of graft vessels. However, there are many other vascular parameters that may potentially influence the outcome of vascular anastomosis and therefore the graft and patient outcomes. To the best of the investigators knowledge, the vascular dimensions of the renal and iliac vessels, such as the length, diameter and site of anastomosis to the iliac vessels have not been studied before so the investigators hypothesis that these dimensions can unequally affect the outcomes of surgery and early graft function in KTs. Hence, this study will be conducted to assess the effects of the vascular dimensions on the outcomes of surgery and primary graft function in pediatric versus adult living donor KT.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

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

Pediatric and adult patients undergoing living donor kidney transplantation.

Description

Inclusion Criteria:

  • Pediatric and adult patients undergoing living donor kidney transplantation.

Exclusion Criteria:

  • Patients with acute graft rejection occurring within the first week of transplantation.
  • Patients refusing participation in the study.

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
Mode of graft function defined by: 1- the time of start of diuresis post-transplantation.
Time Frame: one month post operative.

Mode of graft function defined by:

1- the start of diuresis (sufficient amount of urine production) within one hour of declamping through the first week post-transplantation
one month post operative.
2- Rate of decline of the serum creatinine level.
Time Frame: one month post operative.
2- Rate of decline of the serum creatinine level.
one month post operative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of vascular complications (intra- or perioperative).
Time Frame: one month post operative
The rate of vascular complications (intra- or perioperative): In the form of spasm, hemorrhage, dissection, or thrombosis.
one month post operative
The rate of other surgical complications.
Time Frame: one month post operative
The rate of other surgical complications.
one month post operative

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 2, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • vascular dimensions and KT

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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