Kidney cooling device for Delayed Graft Function

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Delayed Graft Function+2 More
Kidney cooling device - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Delayed Graft Function
  • Transplanted Kidney Complication

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 2 years

2 years
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
5-7 days
Serum creatinine level at discharge from initial hospitalization for transplantation
6 months
Part A: Device design is deemed suitable to move into the traditional feasibility stage (Part B of protocol)
60 minutes
Differences in achieved renal allograft surface temperature comparing the Kidney Skinn (intervention arm) versus usual care (control arm)
7 days
Difference in ischemia-reperfusion injury biomarker levels between the intervention and control groups
Proportion of patients who develop delayed graft function (need for dialysis in the first week after transplantation) compared with usual care

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard transplant surgery practice
1 of 2
Surgery utilizing the Kidney Skinn cooling device
1 of 2
Active Control
Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: Kidney cooling device · No Placebo Group · N/A

Surgery utilizing the Kidney Skinn cooling device
Device
Experimental Group · 1 Intervention: Kidney cooling device · Intervention Types: Device
Standard transplant surgery practiceNoIntervention Group · 1 Intervention: Standard transplant surgery practice · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Nova Scotia Health AuthorityOTHER
232 Previous Clinical Trials
80,052 Total Patients Enrolled
Thomas SkinnerLead Sponsor
Karthik TennankorePrincipal InvestigatorNova Scotia Health Authority

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.