Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

NCT01771003 | Terminated

• 1 other identifier: RIPC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

Partial nephrectomy; renal cell carcinoma; Renal Function; Remote ischemia preconditioning

Outcome Measures

Primary Outcomes (1)

• 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

  up to 2 weeks prior to surgery and up to 24 hrs post surgery

Study Arms (2)

Without CellAegis' autoRIC™ Device

PLACEBO COMPARATOR

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

With CellAegis' autoRIC™ Device

ACTIVE COMPARATOR

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

Interventions

CellAegis' autoRIC™ Device 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; Without CellAegis' autoRIC™ Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be a candidate for laparoscopic partial nephrectomy
• ECOG Performance status of 0-1

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Michael Jewett, M.D.

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: January 18, 2013
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

CA (1)