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

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the kidney cooling device safe for use in humans?

The kidney cooling device has been tested in pigs and shown to effectively cool the kidney without reported safety issues in these animal studies. However, there is no specific safety data available for its use in humans. ^{1 2 3 4 5}

How does the kidney cooling device treatment differ from other treatments for kidney complications?

The kidney cooling device is unique because it uses a specialized cooling system to maintain low temperatures during kidney transplantation, reducing the risk of damage from rewarming. This approach is different from traditional methods as it involves a cooling shell or jacket that preserves the kidney at a safe temperature, potentially improving transplant outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the kidney cooling device treatment?

Research shows that cooling the kidney can protect its function during surgeries by reducing damage from lack of blood flow. In one study, a cooling device successfully lowered kidney temperature in pigs, suggesting it could help in human surgeries too. ^{4 5 11 12 13}

Who Is on the Research Team?

Karthik Tennankore

Principal Investigator

Nova Scotia Health Authority

Thomas Skinner

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. United States pubmed.ncbi.nlm.nih.gov

Study of glomerular and tubular function after in situ cooling of the kidney. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of laparoscopic renal cooling with near-freezing saline irrigation delivered with a standard irrigator aspirator. [2015]

3. France pubmed.ncbi.nlm.nih.gov

[Kidney procurement after rapid cooling in situ through a double intra-aortic balloon]. [2016]

4. China pubmed.ncbi.nlm.nih.gov

[Study on the protective effect of cooling the surface of frozen water on renal function in robotic-assisted laparoscopic nephrect]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a minimally invasive renal cooling device using heat transfer analysis and an in vivo porcine model. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

7. China pubmed.ncbi.nlm.nih.gov

A controllable double-cycle cryogenic device inducing hypothermia for laparoscopic orthotopic kidney transplantation in swine. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Protection of the renal collecting system during radiofrequency ablation with antegrade cold dextrose infusion. [2014]

9. France pubmed.ncbi.nlm.nih.gov

[Cooling shell in renal transplantation. Thermometric evaluation of a prototype]. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Intrarenal and in situ kidney workbench surgery under hypothermia. [2019]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

A revised instrument for the regulated external cooling of the kidney. [2004]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

A revised coil for the external cooling of the kidney. [2004]

13. United States pubmed.ncbi.nlm.nih.gov

A novel method of induced renal hypothermia. [2019]