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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
10˚C deceased donor kidney storage using Traferox XPort
DeviceDeceased 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Delayed graft function
Delayed graft function is defined as the patient requiring dialysis within 7 days after kidney transplant.
Post operative urine output
Total volume of urine output for the first 24 hours after the kidney transplant
Creatinine and estimated glomerular filtration rate trends
Participants serum creatinine and estimated glomerular filtration rate trends will be abstracted from the electronic medical record
Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
Traferox Technology Inc.
Collaborator