A Pilot Study of Renal Hypothermia During Partial Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888641
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : June 9, 2011
Information provided by:
Mayo Clinic

April 24, 2009
April 27, 2009
June 9, 2011
June 2009
May 2011   (Final data collection date for primary outcome measure)
measures of renal function uCrCl be performed for estimation of renal function [ Time Frame: 3 months ]
Overall renal function [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00888641 on Archive Site
Post-operative complication [ Time Frame: 3 months ]
Same as current
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A Pilot Study of Renal Hypothermia During Partial Nephrectomy
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
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
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Kidney Neoplasm
Procedure: Hypothermia
Surround kidney in ice slush for 10 minutes after arterial clamping
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Bradley Leibovich, Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP