Cooling Device for Kidney Complication

(QuitWIT Trial)

Overseen By Laura Sills

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Skinner

Disqualifiers: Living donor, DCD, Highly sensitized, Previous transplant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cooling device designed to protect kidneys during transplant surgery. By maintaining the kidney at 5°C for at least an hour, researchers aim to prevent damage that can occur when the organ warms up during surgery. Participants will undergo surgery either with the standard method or with the new kidney cooling device. Individuals receiving a single kidney from a deceased donor and who have not had a previous kidney transplant may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance kidney transplant outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cooling device is safe for kidney transplant surgery?

Research has shown that cooling devices used during kidney transplant surgery can be safe and helpful. These devices keep the kidney cool, potentially preventing damage during the procedure. One study found that using a cooling device reduced harm and improved the quality of the surgery.

Another study indicated that these devices might increase transplant success by preventing the kidney from overheating, which can cause harm. The devices are designed to maintain a low temperature for the kidney during the operation, helping to protect it.

Overall, promising evidence suggests that these cooling devices are well-tolerated, meaning they don't cause many unwanted effects. However, as with any medical treatment, it's important to consider joining a trial only after understanding the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the kidney cooling device because it offers a new technique for protecting transplanted kidneys during surgery. Unlike traditional transplant methods that rely on general cooling, this device specifically targets the kidney, maintaining its hypothermia through cold saline irrigation during vascular anastomosis. This targeted cooling could potentially reduce complications and improve transplant outcomes by minimizing damage to the kidney cells during surgery.

What evidence suggests that this cooling device is effective for preventing kidney damage during transplant surgery?

Research has shown that cooling devices can help prevent tissue damage caused by a lack of blood flow during transplants, known as warm ischemia. This is crucial because warm ischemia can lead to complications in kidney transplants. In this trial, one arm will use a new kidney cooling device, which studies suggest can lower the kidney's temperature during surgery to prevent damage. The device uses cold saltwater to keep the kidney cool and protected during the transplant. Early results indicate that this device might improve kidney transplant success by reducing potential harm. ^{3 4 6 7 8}

Who Is on the Research Team?

Thomas Skinner

Principal Investigator

Nova Scotia Health Authority

Karthik Tennankore

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are about to receive their first kidney transplant from a deceased donor. They must have given consent and not be highly sensitized (PRA >80%). It's not for those receiving a living donor kidney or with previous transplants.

Inclusion Criteria

Donor declared by traditional neurological determination of death (NDD)

Standard criteria donor (SCD) or Extended criteria donor (ECD)

I am scheduled to receive an organ transplant from a deceased donor.

Exclusion Criteria

Living donor (LD)

I have had a kidney transplant in the past.

I am a donor after my heart has stopped.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Initial Safety Evaluation

A series of consecutive consenting patients to determine device initial safety

6 months

Part B: Randomized-Controlled Pilot Study

Single-centre randomized-controlled pilot study of kidney transplant recipients using the Kidney Skinn device

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker collection and assessment of delayed graft function

7 days

What Are the Treatments Tested in This Trial?

Interventions

• Kidney cooling device

Trial Overview The study is testing a new cooling device designed to keep the donated kidney at or below 5°C during surgery, which could last up to an hour. The goal is to prevent warm ischemia, potentially reducing damage to the transplanted organ.

How Is the Trial Designed?

Group I: Surgery utilizing the Kidney Skinn cooling device Experimental Treatment 1 Intervention

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 II: Standard transplant surgery practice Active Control 1 Intervention

Standard transplant surgery per site practice

Who Is Running the Clinical Trial?

Thomas Skinner

Lead Sponsor

Trials

1

Recruited

50+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38831684/

A Novel Cooling Device for Kidney Transplant Surgery This device is the first of its kind and has the potential to improve kidney transplant outcomes by eliminating WIT during graft implantation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05166460

Novel Cooling Device for the Elimination of Warm Ischemia ... If found effective, this could eliminate warm ischemia and potentially prevent damage to transplanted kidneys. The device may also potentially provide ...

3. frontiersin.org frontiersin.org/journals/medical-technology/articles/10.3389/fmedt.2025.1600784/full

Cooling devices used to avoid warm ischemia time injury ... Introduction: Warm ischemia during kidney transplantation contributes to graft dysfunction. External cooling devices have been developed to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7706140/

An Effective Cooling Device for Minimal-Incision Kidney ... This study investigated the safety and efficacy of a new cooling device for use in minimal-incision kidney transplantation (MIKT).

5. withpower.com withpower.com/trial/phase-ischemia-2022-0607a

Cooling Device for Kidney Complication (QuitWIT Trial) The kidney cooling device is unique because it uses a specialized cooling system to maintain low temperatures during kidney transplantation, reducing the risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380627/

Cooling devices used to avoid warm ischemia time injury ... Warm ischemia during kidney transplantation contributes to graft dysfunction. External cooling devices have been developed to preserve graft ...

7. annalsoftransplantation.com annalsoftransplantation.com/abstract/full/idArt/928773

An Effective Cooling Device for Minimal-Incision Kidney ... It is safe and feasible to carry out MIKT using the new cooling device, which can reduce surgical trauma and improve the quality of vascular anastomosis with ...

8. journals.lww.com journals.lww.com/transplantationdirect/fulltext/2023/03000/protection_from_second_warm_ischemic_injury_using.10.aspx

Protection From Second Warm Ischemic Injury Using a ... TBB can maintain transplanted kidneys at a low temperature during vascular anastomosis, which contributes to the functional preservation of transplanted kidneys ...