Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

Study Overview
=================
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.

Official Title
-----------------
The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Device: CellAegis' autoRIC™ Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Without CellAegis' autoRIC™ Device<br>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<br>* 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<br>|
| Active Comparator: With CellAegis' autoRIC™ Device<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial nephrectomy, renal cell carcinoma, Renal Function, Remote ischemia preconditioning