Clinical trial NCT05166460: Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
Official title: Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant; Complications
Delayed Graft Function
Keywords: kidney
transplant
warm ischemia time
delayed graft function
vascular anastomosis
renal hypothermia
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2021-12-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization (Part B, 40 patients). This will be preceded with a single series of 5 consecutive patients (Part A).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: Warm ischemia can damage a renal allograft in many different ways often leading to early failure of the kidney transplant and sometimes even death of the transplant recipient. For this reason every effort is made to keep the allograft cold during the removal and transportation, and protocols have been developed to ensure this. Although kidneys are kept below 5°C during transportation, they re-warm rapidly during the transplant surgery. On average, kidneys are exposed to 40 or more minutes of dangerously warm temperatures during transplant surgery.

To avoid damage, it is important to reduce the amount of time it is exposed to warm temperatures. Currently, there are no devices or standardized protocols available to ensure a kidney stays cold during the transplant surgery.

The Principal Investigator has developed Kidney Skinn, a device that may control the temperature of the renal allograft during transplant surgery; keeping allograft 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. The device may also potentially provide retraction and support for the kidney during the transplant operation, making the surgery easier to perform. Additionally, the device may be found to be easily removed once the transplant is complete.

A previous study was conducted with the Kidney Skinn in animals; the next step is to investigate whether the device can perform in the human clinical setting. This study will be done in 2 steps. Part A: a series of consecutive consenting patients to determine device initial safety, and Part B: a single-centre randomized-controlled pilot study of kidney transplant recipients.

Eligibility criteria: 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

Primary outcomes:
measure: Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)
timeFrame: 6 months
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care
timeFrame: 7 days
measure: Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups
timeFrame: 7 days
measure: Serum creatinine level at discharge from initial hospitalization for transplantation
timeFrame: 5-7 days
measure: Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Thomas Skinner
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Karthik Tennankore
role: PRINCIPAL_INVESTIGATOR
References: