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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
  Purpose

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 Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative complication [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888641

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

No publications provided

Responsible Party: Bradley Leibovich, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00888641     History of Changes
Other Study ID Numbers: 08-007979
Study First Received: April 24, 2009
Last Updated: June 8, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013