Renal Cell Carcinoma
Conditions
Keywords
Partial nephrectomy, renal cell carcinoma, Renal Function, Remote ischemia preconditioning
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.
Interventions
DEVICECellAegis' 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
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed