Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Kidney transplant candidates less than 18 years old

Kidney transplant candidates that decline consent

Transplant candidates listed for multi-organ transplant

Donation after brain death or donation after circulatory death kidney donors, whose health care proxy has consented for donation and the possibility of research

Trial design

Design model

Parallel

Treatments tested in this trial

  • 10˚C deceased donor kidney storage using Traferox XPort

    Device

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: 10˚C deceased donor kidney storageExperimental treatment 1 intervention
Group B: Conventional (ice storage) deceased donor kidney storageNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Urine NGAL

Neutrophil gelatinase-associated lipocalin (NGAL), a urine biomarker for acute kidney injury that has been shown to be predictive of delayed kidney graft function. Urine will be collected after the kidney transplant, processed and stored with an anonymous ID.

Time frame
Urine collected post operatively day one after kidney transplant

Secondary outcomes

1

Delayed graft function

Delayed graft function is defined as the patient requiring dialysis within 7 days after kidney transplant.

Time frame
Within 7 days after kidney transplant
2

Post operative urine output

Total volume of urine output for the first 24 hours after the kidney transplant

Time frame
24 hours after kidney transplant
3

Creatinine and estimated glomerular filtration rate trends

Participants serum creatinine and estimated glomerular filtration rate trends will be abstracted from the electronic medical record

Time frame
One month post operatively after kidney transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

Traferox Technology Inc.

Collaborator