A Pilot Study of Renal Hypothermia During Partial Nephrectomy

June 8, 2011 updated by: Mayo Clinic
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normothermia
After arterial clamping, no ice slush will be used
Experimental: Hypothermia
After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes
Procedure: Hypothermia
Surround kidney in ice slush for 10 minutes after arterial clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measures of renal function uCrCl be performed for estimation of renal function
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative complication
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-007979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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