A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in Kidney Transplantation

September 20, 2024 updated by: Murat Ferhat Ferhatoglu, Okan University

A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in the Elimination of Warm Ischemic Time in Kidney Transplantation

Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney transplantation on long-term kidney function.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomized clinical trial was conducted at Istanbul Okan University Hospital, Istanbul, Turkey. All participants were selected from those who underwent kidney transplantation between January 2020 and January 2023.

Study Type

Observational

Enrollment (Actual)

172

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

  • Turkey
      • Istanbul, Turkey, 34334
        • Istanbul Okan University
    • Kadıköy
      • Istanbul, Kadıköy, Turkey, 34734
        • Murat Ferhat Ferhatoglu

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

Sampling Method

Non-Probability Sample

Study Population

All individuals were selected from those who underwent Kidney transplantation at our institution between January 2020 and January 2023.

Description

Inclusion Criteria:

-Underwent kidney transplantation surgery

Exclusion Criteria:

- Deceased donor transplantation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Kidney transplantation performed using the ice bag technique.
Other: surgery
In order to preserve kidney from warm ischemia during graft implantation, on the back table, graft were prepared for implantation with standard techniques. The kidney was introduced into the bag which was filled with a small amount of ice and preservation fluid (Figure 1). After inplacement of the graft, a small hole was made near the hilum and the renal artery and vein were passed through the hole. A Kocher clamp was used to maintain the fluid and ice in place and as a handle. Also, a Hartman Mosquito Clamp was used to mark urether-side, and to maintain orientation.
Other Names:
  • Simple plastic bag to preserve kidney from warm ischemia
Group B
Kidney transplantation performed using Raytech sponge technique.
Other: Ray-Tech sponge technique
On the back table, graft were prepared for implantation with standard techniques. A Raytech sponge is soaked in ice-cold preservative solution, and wrapped around the kidney and held with a clamp (Figure 2). Position and oriantation of the graft was done by direct vision of urether.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creatinine decrease
Time Frame: 6 months
Serum creatinine levels at 7th, 30th, 60th, and 180th days after operation were evaluated
6 months

Collaborators and Investigators

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

Sponsor

Okan University

Investigators

  • Principal Investigator: MURAT F FERHATOGLU, MD, Okan 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)

January 1, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No: 161, Date: December 14, 20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing data is not right in terms of patient privacy. When the informed consent form was signed by participants, only information about the study was given. No information was given about data sharing.

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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