A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00888641

Enrollment

Registered

2009-04-27

Start date

2009-06-30

Completion date

2011-05-31

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Neoplasm

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

Interventions

PROCEDUREHypothermia

Surround kidney in ice slush for 10 minutes after arterial clamping

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
measures of renal function uCrCl be performed for estimation of renal function	3 months

Secondary

Measure	Time frame
Post-operative complication	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026