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

April 19, 2023 updated by: Thomas Skinner
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery utilizing the Kidney Skinn cooling device
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
renal cooling device designed to maintain renal hypothermia at or below 5ºC for 60 minutes.
Other Names:
  • Kidney Skinn
No Intervention: Standard transplant surgery practice
Standard transplant surgery per site practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)
Time Frame: 6 months
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
Time Frame: 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care
Time Frame: 7 days
Delayed Graft function as defined by the need for dialysis in the first 7 post operative days
7 days
Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups
Time Frame: 7 days
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
Serum creatinine level at discharge from initial hospitalization for transplantation
Time Frame: 5-7 days
Local laboratory serum creatinine drawn per standard of care on all renal transplant recipients on day of discharge
5-7 days
Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)
Time Frame: 60 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Skinner

Collaborators

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Thomas Skinner, Nova Scotia Health Authority
  • Principal Investigator: Karthik Tennankore, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2023

Primary Completion (Anticipated)

January 15, 2026

Study Completion (Anticipated)

January 15, 2026

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a pilot study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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