Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

University Health Network, Toronto

Status: Terminated

Conditions: Renal Cell Carcinoma

Treatments: Device: CellAegis' autoRIC™ Device

Study type: Interventional

Funder types: Other

Identifiers

NCT01771003

RIPC

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups, including a placebo group

Without CellAegis' autoRIC™ Device

Placebo Comparator group

Description:

patients will have a blood pressure cuff attached to their arm that will not inflate/deflate as in the active group

Treatment:

Device: CellAegis' autoRIC™ Device

With CellAegis' autoRIC™ Device

Active Comparator group

Description:

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)

Treatment:

Device: CellAegis' autoRIC™ Device