45 Participants Needed

Cooling Device for Kidney Complication

(QuitWIT Trial)

TS
LS
Overseen ByLaura Sills
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Skinner
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.45111213

Who Is on the Research Team?

KT

Karthik Tennankore

Principal Investigator

Nova Scotia Health Authority

TS

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.
See 1 more

Exclusion Criteria

Living donor (LD)
I have had a kidney transplant in the past.
I am a donor after my heart has stopped.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgery utilizing the Kidney Skinn cooling deviceExperimental Treatment1 Intervention
Group II: Standard transplant surgery practiceActive Control1 Intervention

Find a Clinic Near You

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

Citations

Study of glomerular and tubular function after in situ cooling of the kidney. [2019]
Feasibility of laparoscopic renal cooling with near-freezing saline irrigation delivered with a standard irrigator aspirator. [2015]
[Kidney procurement after rapid cooling in situ through a double intra-aortic balloon]. [2016]
[Study on the protective effect of cooling the surface of frozen water on renal function in robotic-assisted laparoscopic nephrect]. [2021]
Evaluation of a minimally invasive renal cooling device using heat transfer analysis and an in vivo porcine model. [2016]
Patient-reported and actionable safety events in CKD. [2021]
A controllable double-cycle cryogenic device inducing hypothermia for laparoscopic orthotopic kidney transplantation in swine. [2022]
Protection of the renal collecting system during radiofrequency ablation with antegrade cold dextrose infusion. [2014]
[Cooling shell in renal transplantation. Thermometric evaluation of a prototype]. [2006]
10.United Statespubmed.ncbi.nlm.nih.gov
Intrarenal and in situ kidney workbench surgery under hypothermia. [2019]
11.Czech Republicpubmed.ncbi.nlm.nih.gov
A revised instrument for the regulated external cooling of the kidney. [2004]
12.Czech Republicpubmed.ncbi.nlm.nih.gov
A revised coil for the external cooling of the kidney. [2004]
13.United Statespubmed.ncbi.nlm.nih.gov
A novel method of induced renal hypothermia. [2019]
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