Kidney Transplant; Complications Clinical Trial
— QuitWITOfficial title:
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
Avoiding warm ischemia time during vascular anastomosis of the renal allograft is important to prevent damage. The investigators are studying a cooling device that may control the temperature of the renal allograft during transplant surgery; attempting to keep temperatures at or below 5°C for at least 60 minutes. If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | January 15, 2026 |
Est. primary completion date | January 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. =18 years of age at time of transplant 2. Slated to receive a single cadaveric organ 3. Donor declared by traditional neurological determination of death (NDD) 4. Standard criteria donor (SCD) or Extended criteria donor (ECD) 5. Consent obtained prior to the transplant operation Exclusion Criteria: 1. Living donor (LD) 2. Donor after cardiocirculatory death (DCD) 3. Highly sensitized patients (those with Panel-reactive antibody or PRA >80%) 4. Recipient of a previous kidney transplant |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Thomas Skinner | Nova Scotia Health Authority |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol) | The Kidney Skinn cooling device can be utilized during vascular anastomosis, and the ability of the device to maintain surface and core temperatures of transplant kidneys at <5ºC for the duration of the vascular anastomosis. | 6 months | |
Primary | Part B: To determine the feasibility of a trial using the Kidney Skinn cooling device to usual care to ameliorate warm ischemia time during kidney transplantation | Feasibility Outcomes will include the following:
Ability to randomize >60% of eligible patients >75% of patients randomized to the Kidney Skinn arm use the device 70% of patients randomized to the device (Kidney Skinn) achieve a renal allograft surface temperature of <5C for the duration of the vascular anastomosis. |
2 years | |
Secondary | Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care | Delayed Graft function as defined by the need for dialysis in the first 7 post operative days | 7 days | |
Secondary | Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups | Urine and serum biomarkers for ischemia-reperfusion injury will be collected at specific key time points pre and post transplantation on all Part B trial participants. Specifically, urine and serum samples for unique markers of kidney injury (KIM-1 & NGAL), inflammation (TNFR1, MCP-1) and fibrosis (suPAR, YKL 40). | 7 days | |
Secondary | Serum creatinine level at discharge from initial hospitalization for transplantation | Local laboratory serum creatinine drawn per standard of care on all renal transplant recipients on day of discharge | 5-7 days | |
Secondary | Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm) | For each surgery, K-type 30 gauge thermocouples (each less than 0.25mm in external diameter) will be used in the renal allograft at a depth of 5 mm and 15 mm. This will be to measure surface (cortical) and core (medullary) temperatures, respectively. | 60 minutes |
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