A Pilot Study of Renal Hypothermia During Partial Nephrectomy

This study has been completed.

Sponsor:

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00888641

First received: April 24, 2009

Last updated: June 8, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 24, 2009
Last Updated Date	June 8, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2011)	measures of renal function uCrCl be performed for estimation of renal function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: April 24, 2009)	Overall renal function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00888641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 24, 2009)	Post-operative complication [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Official Title ^ICMJE	A Pilot Study of Renal Hypothermia During Partial Nephrectomy
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Kidney Neoplasm
Intervention ^ICMJE	Procedure: Hypothermia Surround kidney in ice slush for 10 minutes after arterial clamping
Study Arm (s)	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 Intervention: Procedure: Hypothermia
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology. Bilateral renal function on radiographic imaging. Willing to consent to randomization. Willing to comply with study protocol. Exclusion Criteria: Anatomically or functionally solitary kidney Multiple renal tumours Bilateral renal tumours Life expectancy < 3 months as deemed by treating physician Age less than 18 years old Pregnancy
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00888641
Other Study ID Numbers ^ICMJE	08-007979
Has Data Monitoring Committee	No
Responsible Party	Bradley Leibovich, Mayo Clinic
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mayo Clinic
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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