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Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

Sponsor
University Health Network, Toronto (Other)
Overall Status
Terminated
CT.gov ID
NCT01771003
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
23
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CellAegis' autoRIC™ Device
 N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2012
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Kidney Function before and after surgery [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01771003
Other Study ID Numbers:
  • RIPC
First Posted:
Jan 18, 2013
Last Update Posted:
Dec 10, 2015
Last Verified:
Dec 1, 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

Study Results

No Results Posted as of Dec 10, 2015