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

NCT ID: NCT06611189

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Disease Stage V

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Kidney transplantation performed using the ice bag technique.

surgery

Intervention Type OTHER

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.

Group B

Kidney transplantation performed using Raytech sponge technique.

Ray-Tech sponge technique

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Simple plastic bag to preserve kidney from warm ischemia

Eligibility Criteria

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Inclusion Criteria

-Underwent kidney transplantation surgery

Exclusion Criteria

\- Deceased donor transplantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Okan University

OTHER

Sponsor Role lead

Responsible Party

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Murat Ferhat Ferhatoglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MURAT F FERHATOGLU, MD

Role: PRINCIPAL_INVESTIGATOR

Okan University

Locations

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Murat Ferhat Ferhatoglu

Istanbul, Kadıköy, Turkey (Türkiye)

Site Status

Istanbul Okan University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ferede AA, Walsh AL, Davis NF, Smyth G, Mohan P, Power R, Forde J, O'Kelly P, Llittle D. Warm Ischemia Time at Vascular Anastomosis is an Independent Predictor for Delayed Graft Function in Kidney Transplant Recipients. Exp Clin Transplant. 2020 Feb;18(1):13-18. doi: 10.6002/ect.2018.0377. Epub 2019 Jul 2.

Reference Type BACKGROUND
PMID: 31266437 (View on PubMed)

Ide K, Sakai H, Nakano R, Imaoka Y, Tanimine N, Ide R, Tsukiyama N, Ono K, Mochizuki T, Arata R, Hakoda K, Imaoka K, Fukuhara S, Bekki T, Tahara H, Ohira M, Kobayashi E, Ohdan H. Effectiveness of Thermal Barrier Bag for Prolonged Vascular Anastomosis in Kidney Transplantation. Transplant Proc. 2023 May;55(4):752-755. doi: 10.1016/j.transproceed.2023.03.004. Epub 2023 Apr 6.

Reference Type BACKGROUND
PMID: 37028949 (View on PubMed)

Ide K, Nakano R, Imaoka Y, Sakai H, Ono K, Tanimine N, Tahara H, Ohira M, Ueda K, Hirata T, Kobayashi E, Ohdan H. Protection From Second Warm Ischemic Injury Using a Thermal Barrier Bag in Kidney Transplantation. Transplant Direct. 2023 Feb 17;9(3):e1454. doi: 10.1097/TXD.0000000000001454. eCollection 2023 Mar.

Reference Type BACKGROUND
PMID: 36845857 (View on PubMed)

Other Identifiers

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No: 161, Date: December 14, 20

Identifier Type: -

Identifier Source: org_study_id

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