Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

This study has been terminated.
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: October 29, 2012
Last updated: June 30, 2015
Last verified: January 2013
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

Enrollment: 21
Study Start Date: October 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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


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

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
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Please refer to this study by its identifier: NCT01771003

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

No publications provided

Responsible Party: University Health Network, Toronto Identifier: NCT01771003     History of Changes
Other Study ID Numbers: RIPC
Study First Received: October 29, 2012
Last Updated: June 30, 2015
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, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on November 27, 2015