A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Kidney Neoplasm Clinical Trial

Official title:

A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888641
• Other study ID #: 08-007979
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2009
• Last updated: June 8, 2011
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Kidney Neoplasm
• Kidney Neoplasms

Intervention

Procedure:
• Hypothermia
Surround kidney in ice slush for 10 minutes after arterial clamping

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measures of renal function uCrCl be performed for estimation of renal function		3 months	No
Secondary	Post-operative complication		3 months	Yes