RenalGuard is designed to reduce the toxic effects that contrast media can have on the kidneys, which may lead to a reduction in the incidence of Contrast-Associated AKI (CA-AKI) in at-risk patients. RenalGuard Therapy® is based on existing published literature, including the PRINCE study1, which support the theory that creating and maintaining a high urine output through the kidneys allows the body to rapidly eliminate contrast, reducing its toxic effects.
RenalGuard Therapy entails the use of a physician-prescribed loop diuretic which may induce the required high urine output. The system is designed to measure urine output and replaces it in real-time with an equal volume of sterile saline. This matched fluid replacement aims to minimize the risk of over- or under-hydration which can lead to increased patient risks.
RenalGuard has been shown in two investigator sponsored studies to significantly reduce the incidence of Contrast-Associated AKI when compared to the standard of care. The device is comprised of a Console and a RenalGuard Single Use Set for infusion and urine collection. The Single Use Set contains a urine collection set which connects to a patient’s Foley catheter and an infusion set which connects to a standard IV catheter. The Console measures the volume of urine in the collection set and infuses an equal volume of hydration fluid to match the patient’s urine output. The Console relies on proprietary, patented software and electronic weight measurements to control the rate at which fluid is infused and to monitor urine volume.
In addition to urine volume replacement, a user can set the RenalGuard System to achieve a net fluid gain over and above matched hydration or to achieve a net fluid loss. RenalGuard allows infusion of a bolus of fluid at the user’s request. In addition, the device is capable of adjusting matched hydration to take into account other fluid sources.