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

April 24, 2009
June 8, 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 ] [ Designated as safety issue: No ]
Overall renal function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00888641 on ClinicalTrials.gov Archive Site
Post-operative complication [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00888641
08-007979
No
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