Abstract
BackgroundAcute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI.Methods/DesignReduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure.DiscussionThe Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI.Trial registrationClinicaltrials.gov: NCT01866800, 30 April 30 2013.
Highlights
Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality
The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI
Under the assumption that AKI is relatively common (40%) after TAVI, and that the RenalGuard system has been shown to reduce the incidence of AKI by up to 70% [3,4], we estimated that if there will be a 50% reduction in AKI in the RenalGuard group, the number of patients needed in each group to attain 80% power with an alpha of 0.05, is 92
Summary
Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. Two randomized controlled trials have demonstrated that furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system (PLC Medical Systems, Milford, Massachusetts, USA) [3,4] reduces AKI in high-risk patients undergoing coronary procedures. Patients undergoing TAVI have a high prevalence of chronic kidney disease (CKD) and are at increased risk to develop AKI (Table 1). AKI has been observed in up to 41% of patients
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