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A Pilot Study of Renal Hypothermia During Partial Nephrectomy

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: April 24, 2009
Last updated: June 8, 2011
Last verified: June 2011
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

Condition Intervention Phase
Kidney Neoplasm Procedure: Hypothermia Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • measures of renal function uCrCl be performed for estimation of renal function [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Post-operative complication [ Time Frame: 3 months ]

Enrollment: 13
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00888641

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Bradley Leibovich, Mayo Clinic Identifier: NCT00888641     History of Changes
Other Study ID Numbers: 08-007979
Study First Received: April 24, 2009
Last Updated: June 8, 2011

Additional relevant MeSH terms:
Kidney Neoplasms
Body Temperature Changes
Signs and Symptoms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017