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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypothermia

Procedure

Surround kidney in ice slush for 10 minutes after arterial clamping

Primary outcomes

measures of renal function uCrCl be performed for estimation of renal function

Time frame: 3 months

Secondary outcomes

Post-operative complication

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Apr 27, 2009
Registry last updated: Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed