PLC Systems reports that the first patient has been treated in a study designed to evaluate the effectiveness of its RenalGuard therapy for preventing acute kidney injury in patients undergoing transcatheter aortic valve implantation.
The study was initiated at Tel Aviv Sourasky Medical Center in Israel by Yaron Arbel, who is the Director of the hospital’s Cardio Vascular Research Center. It is expected to enroll up to 200 patients and will evaluate whether forced diuresis with matched hydration will reduce the incidence of contrast induced nephropathy in patients undergoing TAVI. Patients will be randomised to receive either RenalGuard or placebo comparator. The primary endpoint is the reduction of acute kidney injury at 48–72 hours.
According to a press release, RenalGuard is intended to prevent acute kidney injury by achieving high urine output safely through automatic and continuous measuring of the patient’s urine output and matching that volume by infusing an equal volume of hydration fluid. It allows patients to receive as much fluid as they produce while minimising the risk of over- or under-hydration. In two previously conducted studies, the therapy has been shown to reduce the incidence of acute renal failure following cardiac catheterisation.
Mark R Tauscher, president and CEO of PLC Systems, says: “TAVI is one of many in-hospital procedures that can lead to acute kidney injury. This hospital-initiated study will be a major contribution to the science of acute kidney injury in these high-profile TAVI cases. We are excited that Dr Arbel is using the RenalGuard therapy on TAVI patients, which supports our commitment to expand patient use of our RenalGuard therapy.”