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-Induced Nephropathy (CIN) 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.
|KIDNEY||Heyman Luckraz, MD||Assess the impact of the RenalGuard(r) system on the reduction of AKI in patients undergoing cardiac surgery||In patients at-risk for AKI, undergoing cardiac surgery with the cardiac pulmonary bypass, the RenalGuard system significantly reduced the incidence of AKI. The RenalGuard system can be used safely and reproducibly in Cardiac Surgery.|
|REMEDIAL III||Carlo Briguori, MD||Evaluate the ability of the two most successful patient “tailored hydration regimens” to protect at-risk patients from CI-AKI by comparing RenalGuard Therapy with left ventricular end-diastolic pressure (LVEDP)-guided hydration (the “POSEIDON” method).||The investigators concluded that RenalGuard Therapy is superior to the LVEDP-guided hydration regimen to prevent the composite of CI-AKI and/or acute pulmonary edema in high-risk patients.|
|PROTECT-TAVI (Complete)||Marco Barbanti, MD||Investigate the effect of the RenalGuard System on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR).||Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.|
|AKIGuard (Complete)||Tullio Usmiani, MD||Compare sodium bicarbonate/isotonic saline/N-acetylcysteine/vitamin C prophylaxis (BS-NAC) against high-volume forced diuresis with matched hydration in CI-AKI prevention in patients with chronic kidney disease undergoing coronary angiography or percutaneous coronary intervention.||Demonstrated significant improvement in long-term outcomes when using RenalGuard vs. standard therapy.|
|MYTHOS (Complete)||Antonio Bartorelli, MD
Giancarlo Marenzi, MD
|Compare the rates of CIN in at-risk patient who receive induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to patients who receive standard overnight hydration.||Patients who were at higher risk for renal failure and who were treated with RenalGuard while undergoing imaging procedures developed CIN at a rate 74% lower than those who were treated with overnight hydration.|
|REMEDIAL II (Complete)||Carlo Briguori, MD||Study the efficacy of RenalGuard Therapy compared to the current standard of care.||RenalGuard Therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients.|
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 CIN 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.
1 Stevens, MA, McCullough, PA et al. A prospective randomized trial of prevention measures in patients at high risk for contrast nephropathy. JACC 1999;33:403-11
RenalGuard is CE-marked for the intended use of temporary (up to 14 days) replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient’s intravascular fluid volume. The RenalGuard System is not intended for infusion of blood, blood components, medications, or nutritional fluids. All treatments administered via The RenalGuard System must be prescribed by a physician. RenalGuard Solutions, Inc. reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation. Caution – Investigational Device, Limited By United States Law to Investigational Use.
The following papers and abstracts discuss the use of RenalGuard Therapy in the prevention of Contrast-Induced Kidney Injury (CIN).