Cooling Device for Kidney Complication
(QuitWIT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byKarthik Tennankore

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thomas Skinner

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

I am 18 years old or older.

Donor declared by traditional neurological determination of death (NDD)

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

+2 more

Exclusion Criteria

Living donor (LD)

I have had a kidney transplant in the past.

I am a donor after my heart has stopped.

+1 more

Participant Groups

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.

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