Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation

NCT05166460 | Unknown DMC

• 1 other identifier: 1026704
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Delayed Graft Function

Keywords

kidney; transplant; warm ischemia time; delayed graft function; vascular anastomosis; renal hypothermia

Outcome Measures

Primary Outcomes (2)

• 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

• 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: 1. Ability to randomize \>60% of eligible patients 2. \>75% of patients randomized to the Kidney Skinn arm use the device 3. 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 Outcomes (4)

• Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care

  7 days

• Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups

  7 days

• Serum creatinine level at discharge from initial hospitalization for transplantation

  5-7 days

• Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)

  60 minutes

Study Arms (2)

Surgery utilizing the Kidney Skinn cooling device

EXPERIMENTAL

All patients in Part A, and those randomized to the Kidney Skinn arm in Part B, will receive transplant surgery in the traditional fashion with the exception that the renal allograft will be placed in the cooling device at the initiation of the vascular anastomosis. Cold saline irrigation flowing through the device will be used to maintain renal hypothermia for the duration for the vascular anastomosis. After the vascular clamps are released, the device will be removed.

Device: Kidney cooling device

Standard transplant surgery practice

NO INTERVENTION

Standard transplant surgery per site practice

Interventions

Kidney cooling device DEVICE

renal cooling device designed to maintain renal hypothermia at or below 5ºC for 60 minutes.

Also known as: Kidney Skinn

Surgery utilizing the Kidney Skinn cooling device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age at time of transplant
• Slated to receive a single cadaveric organ
• Donor declared by traditional neurological determination of death (NDD)
• Standard criteria donor (SCD) or Extended criteria donor (ECD)
• Consent obtained prior to the transplant operation

You may not qualify if:

• Living donor (LD)
• Donor after cardiocirculatory death (DCD)
• Highly sensitized patients (those with Panel-reactive antibody or PRA \>80%)
• Recipient of a previous kidney transplant

Sponsors & Collaborators

• Thomas Skinner: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Skinner

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Karthik Tennankore

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Skinner

CONTACT

902-425-3940; tomaaskinner@gmail.com

Laura Sills

CONTACT

902-473-7625; laura.sills@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 randomization (Part B, 40 patients). This will be preceded with a single series of 5 consecutive patients (Part A).

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: December 22, 2021
• Study Start: October 1, 2023
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)