RecruitingNot ApplicableNCT07385651

Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage


Sponsor

Vanderbilt University Medical Center

Enrollment

30 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test how storage temperature of deceased donor kidneys affects kidney function after transplant in adult patients receiving a kidney transplant. The main question it aims to answer is: • Do patients that receive a kidney transplant stored at 10 °C have improved post-transplant kidney function? Researchers will compare patients who receive kidneys stored at 10 °C versus kidneys stored at 4°C (on ice, i.e. conventional storage) to see if kidneys stored at 10 °C have improved function. Participants will: * Be made aware of and consent to receive a kidney transplant that had been stored at 10 °C * Have their urine collected 24 hours after surgery to be analyzed for research


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • \. All adult single organ kidney transplant candidates on the waiting list at Vanderbilt University Medical Center (VUMC) will be eligible for enrollment.
  • Donation after brain death or donation after circulatory death kidney donors, whose health care proxy has consented for donation and the possibility of research
  • Deceased donor kidneys that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible

Exclusion Criteria7

  • Kidney transplant candidates less than 18 years old
  • Kidney transplant candidates that decline consent
  • Transplant candidates listed for multi-organ transplant
  • Donors whose health care proxy has declined consent for the possibility of research
  • Deceased donor kidneys that have been allocated to VUMC as a backup offer
  • Deceased donor kidneys that have been allocated to VUMC as a post procurement offer
  • Deceased donor kidneys that have already been placed on ice

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Interventions

DEVICE10˚C deceased donor kidney storage using Traferox XPort

Deceased donor kidneys will be stored using the Traferox XPort device to maintain an organ temperature of 10˚C during storage and transport until the time of transplant


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT07385651


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