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

NCT06611189 | Active Not Recruiting

• 1 other identifier: No: 161, Date: December 14, 20
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Kidney Disease Stage V

Keywords

Kidney transplantation; Warm ischemia

Outcome Measures

Primary Outcomes (1)

• Creatinine decrease

  Serum creatinine levels at 7th, 30th, 60th, and 180th days after operation were evaluated

  6 months

Study Arms (2)

Group A

Kidney transplantation performed using the ice bag technique.

Other: surgery

Group B

Kidney transplantation performed using Raytech sponge technique.

Other: Ray-Tech sponge technique

Interventions

surgery 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.

Also known as: Simple plastic bag to preserve kidney from warm ischemia

Group A

Ray-Tech sponge technique 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.

Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Underwent kidney transplantation surgery

You may not qualify if:

• \- Deceased donor transplantation

Sponsors & Collaborators

• Okan University: lead

Study Sites (2)

Murat Ferhat Ferhatoglu

Istanbul, Kadıköy, 34734, Turkey (Türkiye)

Location

Istanbul Okan University

Istanbul, 34334, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31266437 BACKGROUND

• 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.

  PMID: 37028949 BACKGROUND

• 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.

  PMID: 36845857 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• MURAT F FERHATOGLU, MD

  Okan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 24, 2024
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)