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Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

NCT ID: NCT01771003

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Keywords

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Partial nephrectomy renal cell carcinoma Renal Function Remote ischemia preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type PLACEBO_COMPARATOR

CellAegis' autoRIC™ Device

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

CellAegis' autoRIC™ Device

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Jewett, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RIPC

Identifier Type: -

Identifier Source: org_study_id