The KIDNEY study, Kidney Protection Using the RenalGuard® System in Cardiac Surgery, is a 220 patient randomized clinical trial comparing the effectiveness automated diuresis technology to standard hydration for the prevention of AKI in patients undergoing cardiac surgery with cardiopulmonary bypass.
In the KIDNEY trial, patients at-risk for AKI were randomized into either a RenalGuard Therapy treatment group or a control group managed with standard-of-care hydration. Risk factors for AKI included a history of diabetes and or anemia; estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.72m2; anticipated cardiac surgery time >120 minutes and Log EuroScore > 5. AKI was defined as a rise in serum creatinine greater than 50% in the days post-procedure.
The RenalGuard group’s post-operative AKI rates were significantly lower than the control group’s, 10% vs 20.9%. As well, the mean volumes of urine produced during surgery (2337 + 896 ml vs 766 + 557 ml) and within 24 hours post-op in ICU (3297 + 1298 ml vs 2053 + 802 ml) were significantly higher in the RenalGuard group. Median ICU stays were similar for the two groups.
The investigators concluded that for 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.