Storing deceased donor kidneys at 10°C instead of on ice (4°C)
Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage
This trial will try to see if deceased donor kidneys stored at 10°C help adult transplant recipients have better kidney function after transplant compared with kidneys stored on ice (4°C).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07385651 on ClinicalTrials.gov |
What this trial studies
Researchers will compare outcomes in adults listed for single-organ kidney transplant at Vanderbilt who receive deceased donor kidneys stored at 10°C using the Traferox XPort device versus conventional storage on ice at 4°C. Participants who consent will receive an allocated kidney and have urine collected 24 hours after surgery for biomarker analysis related to ischemia-reperfusion injury and graft function. The trial is motivated by preclinical data showing reduced mitochondrial injury and reactive oxygen species at milder cold temperatures and aims to measure clinical graft function, including rates of delayed graft function. Outcomes will inform whether a change in storage temperature can improve early post-transplant recovery.
Who should consider this trial
Good fit: Adult (≥18) single-organ kidney transplant candidates listed at Vanderbilt University Medical Center who consent to receive a deceased donor kidney stored at 10°C are eligible.
Not a fit: Children under 18, candidates listed for multi-organ transplants, patients who decline consent, and recipients of living-donor kidneys are not eligible and would not be expected to benefit from this specific storage approach.
Why it matters
Potential benefit: If successful, 10°C storage could reduce delayed graft function and improve short- and long-term graft outcomes for deceased donor kidney recipients.
How similar studies have performed: Preclinical porcine and other organ studies (including lungs) have shown reduced cell injury and markers of mitochondrial damage with 10°C storage, but clinical data in human kidney transplantation remain limited and novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Participant inclusion criteria 1\. All adult single organ kidney transplant candidates on the waiting list at Vanderbilt University Medical Center (VUMC) will be eligible for enrollment. Participant exclusion criteria 1. Kidney transplant candidates less than 18 years old 2. Kidney transplant candidates that decline consent 3. Transplant candidates listed for multi-organ transplant Deceased donor organ inclusion criteria: 1. Donation after brain death or donation after circulatory death kidney donors, whose health care proxy has consented for donation and the possibility of research 2. Deceased donor kidneys that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible Deceased donor organ exclusion criteria: 1. Donors whose health care proxy has declined consent for the possibility of research 2. Deceased donor kidneys that have been allocated to VUMC as a backup offer 3. Deceased donor kidneys that have been allocated to VUMC as a post procurement offer 4. Deceased donor kidneys that have already been placed on ice
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: W. Christian Crannell, MD — Vanderbilt University Medical Center
- Study coordinator: W. Christian Crannell, MD
- Email: christian.crannell@vumc.org
- Phone: 615-322-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.