A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Kidney Neoplasm

Treatments: Procedure: Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT00888641

08-007979

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Normothermia

No Intervention group

Description:

After arterial clamping, no ice slush will be used

Hypothermia

Experimental group

Description:

After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes

Treatment:

Procedure: Hypothermia