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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

Must not have

Donor after cardiocirculatory death (DCD)

Recipient of a previous kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a donor after my heart has stopped.

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I have had a kidney transplant in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met