Back to resultsA Pilot Study of Renal Hypothermia During Partial Nephrectomy
Primary Purpose
Kidney Neoplasm
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypothermia
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
- Bilateral renal function on radiographic imaging.
- Willing to consent to randomization.
- Willing to comply with study protocol.
Exclusion Criteria:
- Anatomically or functionally solitary kidney
- Multiple renal tumours
- Bilateral renal tumours
- Life expectancy < 3 months as deemed by treating physician
- Age less than 18 years old
- Pregnancy
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Normothermia
Hypothermia
Arm Description
After arterial clamping, no ice slush will be used
After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes
Outcomes
Primary Outcome Measures
measures of renal function uCrCl be performed for estimation of renal function
Secondary Outcome Measures
Post-operative complication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00888641
Brief Title
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Official Title
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normothermia
Arm Type
No Intervention
Arm Description
After arterial clamping, no ice slush will be used
Arm Title
Hypothermia
Arm Type
Experimental
Arm Description
After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes
Intervention Type
Procedure
Intervention Name(s)
Hypothermia
Intervention Description
Surround kidney in ice slush for 10 minutes after arterial clamping
Primary Outcome Measure Information:
Title
measures of renal function uCrCl be performed for estimation of renal function
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Post-operative complication
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
Bilateral renal function on radiographic imaging.
Willing to consent to randomization.
Willing to comply with study protocol.
Exclusion Criteria:
Anatomically or functionally solitary kidney
Multiple renal tumours
Bilateral renal tumours
Life expectancy < 3 months as deemed by treating physician
Age less than 18 years old
Pregnancy
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
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