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

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

Condition or disease Intervention/treatment Phase
Kidney Neoplasm Procedure: Hypothermia Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Study Start Date : June 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888641

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

Responsible Party: Bradley Leibovich, Mayo Clinic Identifier: NCT00888641     History of Changes
Other Study ID Numbers: 08-007979
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Kidney Neoplasms
Body Temperature Changes
Signs and Symptoms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases