Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

Renal Cell Carcinoma Clinical Trial

Official title:

The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01771003
• Other study ID #: RIPC
• Status: Terminated
• Phase: N/A
• First received: October 29, 2012
• Last updated: December 9, 2015
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Reveiw CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No