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Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

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ClinicalTrials.gov Identifier: NCT01771003
Recruitment Status : Terminated
First Posted : January 18, 2013
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment
Renal Cell Carcinoma Device: CellAegis' autoRIC™ Device

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy
Study Start Date : October 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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
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



Primary Outcome Measures :
  1. Change in Kidney Function before and after surgery [ Time Frame: up to 2 weeks prior to surgery and up to 24 hrs post surgery ]
    To measure and compare kidney function (Cr, eGFR) and AKI biomarkers in patients undergoing partial nephrectomy with and without RIPC



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771003


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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01771003     History of Changes
Other Study ID Numbers: RIPC
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

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

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