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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Transplant; Complications Delayed Graft Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Kidney cooling device

Intervention Type DEVICE

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

Standard transplant surgery practice

Standard transplant surgery per site practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kidney cooling device

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

Intervention Type DEVICE

Other Intervention Names

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Kidney Skinn

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No