Back to resultsRemote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CellAegis' autoRIC™ Device
Sponsored by
About this trial
This is an interventional prevention trial for Renal Cell Carcinoma focused on measuring Partial nephrectomy, renal cell carcinoma, Renal Function, Remote ischemia preconditioning
Eligibility 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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Without CellAegis' autoRIC™ Device
With CellAegis' autoRIC™ Device
Arm Description
patients will have a blood pressure cuff attached to their arm that will not inflate/deflate as in the active group
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)
Outcomes
Primary Outcome Measures
Change in Kidney Function before and after surgery
To measure and compare kidney function (Cr, eGFR) and AKI biomarkers in patients undergoing partial nephrectomy with and without RIPC
Secondary Outcome Measures
Full Information
NCT ID
NCT01771003
First Posted
October 29, 2012
Last Updated
December 9, 2015
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01771003
Brief Title
Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy
Official Title
The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Partial nephrectomy, renal cell carcinoma, Renal Function, Remote ischemia preconditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without CellAegis' autoRIC™ Device
Arm Type
Placebo Comparator
Arm Description
patients will have a blood pressure cuff attached to their arm that will not inflate/deflate as in the active group
Arm Title
With CellAegis' autoRIC™ Device
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
CellAegis' autoRIC™ Device
Intervention Description
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 Measure Information:
Title
Change in Kidney Function before and after surgery
Description
To measure and compare kidney function (Cr, eGFR) and AKI biomarkers in patients undergoing partial nephrectomy with and without RIPC
Time Frame
up to 2 weeks prior to surgery and up to 24 hrs post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Jewett, M.D.
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy
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