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Cooling Device

Cooling Device for Kidney Complication (QuitWIT Trial)

N/A

Waitlist Available

Led By Karthik Tennankore

Research Sponsored by Thomas Skinner

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age at time of transplant

Slated to receive a single cadaveric organ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

QuitWIT Trial Summary

This trial is testing a cooling device that may help prevent damage to transplanted kidneys by keeping temperatures at or below 5°C for at least 60 minutes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves a device rather than medication, side effects may include potential complications related to maintaining low temperatures in the organ during transplantation.

QuitWIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have given my consent for the transplant surgery.

QuitWIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)

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

Secondary outcome measures

Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups

Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)

Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care

+1 more

QuitWIT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgery utilizing the Kidney Skinn cooling deviceExperimental Treatment1 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 practiceActive Control1 Intervention

Standard transplant surgery per site practice

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityOTHER

258 Previous Clinical Trials

83,809 Total Patients Enrolled

Thomas SkinnerLead Sponsor

Karthik TennankorePrincipal InvestigatorNova Scotia Health Authority

Media Library

Kidney cooling device (Cooling Device) Clinical Trial Eligibility Overview. Trial Name: NCT05166460 — N/A

Delayed Graft Function Research Study Groups: Surgery utilizing the Kidney Skinn cooling device, Standard transplant surgery practice

Delayed Graft Function Clinical Trial 2023: Kidney cooling device Highlights & Side Effects. Trial Name: NCT05166460 — N/A

Kidney cooling device (Cooling Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166460 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can the research team accommodate for this experiment?

"Confirmed. The trial's record on clinicaltrials.gov reveals that the study is presently recruiting new participants to join and began accepting applications since February 4th, 2022. 45 people are needed across 1 site for a satisfactory test sample size."

Answered by AI

Are any new participants still being sought for this research study?

"As of this moment, clinicaltrials.gov is advertising for patients to participate in a medical study that was initially posted on February 4th 2022 and revised two months later in April 19th 2021."

Answered by AI

What are the underlying goals of this investigation?

"This 6-month long trial seeks to evaluate the impact of Kidney Skinn cooling device versus usual care on warm ischemia time during kidney transplantation. Secondary objectives include assay of renal allograft surface & core temperature, serum creatinine levels at discharge from initial hospitalization for transplantation, and comparison between intervention & control arms in terms of biomarkers related to ischemia-reperfusion injury (KIM-1/NGAL/TNFR1/MCP-1/suPAR/YKL 40)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Thomas Skinner 2023. "Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05166460.

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