Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

Not Applicable

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Device: CellAegis' autoRIC™ Device

• Registration Number: NCT01771003
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-18
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without CellAegis' autoRIC™ Device	CellAegis' autoRIC™ Device	patients will have a blood pressure cuff attached to their arm that will not inflate/deflate as in the active group
With CellAegis' autoRIC™ Device	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada