Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01771003
First received: October 29, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Partial Nephrectomy has become the standard treatment in patients with tumours <7cm (T1). Even though this is a nephron sparing surgery, there is still potential for acute kidney injury, due to ischemia during the surgery. Remote Ischemia Preconditioning may prevent acute kidney injury and in turn chronic kidney disease. Remote Ischemia pre-conditioning involves applying a blood pressure cuff and inflating and deflating several times immediately prior to surgery.


Condition Intervention
Renal Cell Carcinoma
Device: CellAegis' autoRIC™ Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Change in Kidney Function before and after surgery [ Time Frame: up to 2 weeks prior to surgery and up to 24 hrs post surgery ] [ Designated as safety issue: No ]
    To measure and compare kidney function (Cr, eGFR) and AKI biomarkers in patients undergoing partial nephrectomy with and without RIPC


Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Without CellAegis' autoRIC™ Device
patients will have a blood pressure cuff attached to their arm that will not inflate/deflate as in the active group
Active Comparator: With CellAegis' autoRIC™ Device
Patients will have the CellAegis' autoRIC™ Device attached and it will inflate to 200 mmHg in four 5 minute cycles with intervening 5 minutes of reperfusion with the cuff deflated between cycles (while under general anesthetic)
Device: CellAegis' autoRIC™ Device
Patients in the active group will have the autoRIC device (like a blood pressure cuff) inflated and deflated to a pressure of 200 mmHg in four 5 minute cycles with intervening 5 minutes of reperfusion with the cuff deflated between cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be a candidate for laparoscopic partial nephrectomy
  • ECOG Performance status of 0-1

Exclusion Criteria:

  • No diagnosis of any current cutaneous, vascular or neural disease in the right upper arm.
  • If the patient received isoflurane for any indication during the operation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771003

Contacts
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Michael Jewett, M.D. University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01771003     History of Changes
Other Study ID Numbers: RIPC
Study First Received: October 29, 2012
Last Updated: January 15, 2013
Health Authority: Canada: Ethics Reveiw Committee
Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Partial nephrectomy
renal cell carcinoma
Renal Function
Remote ischemia preconditioning

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014