NCT00888641

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

April 24, 2009

Last Update Submit

June 8, 2011

Conditions

Kidney Neoplasm

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

  • Post-operative complication

    3 months

Study Arms (2)

Normothermia

NO INTERVENTION

After arterial clamping, no ice slush will be used

Hypothermia

EXPERIMENTAL

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

Procedure: Hypothermia

Interventions

HypothermiaPROCEDURE

Surround kidney in ice slush for 10 minutes after arterial clamping

Hypothermia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations

US(1)