Kidney cooling device for Delayed Graft Function

Phase-Based Progress Estimates

Effectiveness

Safety

Delayed Graft Function+2 More

Kidney cooling device - Device

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

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

Other trials for Delayed Graft Function

OrganOx Metra

Direct Peritoneal Resuscitation

Liver Machine Perfusion (MP) device

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

Other trials for Delayed Graft Function

OrganOx Metra

Direct Peritoneal Resuscitation

Liver Machine Perfusion (MP) device

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 - 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.

References