A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Phase 1

Completed

• Conditions: Kidney Neoplasm
• Interventions: Procedure: Hypothermia

• Registration Number: NCT00888641
• Lead Sponsor: Mayo Clinic

Brief Summary

Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-06
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
2. Bilateral renal function on radiographic imaging.
3. Willing to consent to randomization.
4. Willing to comply with study protocol.

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Exclusion Criteria

1. Anatomically or functionally solitary kidney
2. Multiple renal tumours
3. Bilateral renal tumours
4. Life expectancy < 3 months as deemed by treating physician
5. Age less than 18 years old
6. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermia	Hypothermia	After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes

Primary Outcome Measures

Name	Time	Method
measures of renal function uCrCl be performed for estimation of renal function	3 months

Secondary Outcome Measures

Name	Time	Method
Post-operative complication	3 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States