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Open Access Study protocol

Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

Yaron Arbel, Eyal Ben-Assa*, Amir Halkin, Gad Keren, Arie Lorin Schwartz, Ofer Havakuk, Eran Leshem-Rubinow, Maayan Konigstein, Arie Steinvil, Yigal Abramowitz, Ariel Finkelstein and Shmuel Banai

Author Affiliations

Department of Cardiology, Tel-Aviv Medical Center affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, 6 Weizman Street, Tel Aviv, Israel

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Trials 2014, 15:262  doi:10.1186/1745-6215-15-262

Published: 2 July 2014

Abstract

Background

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.

Methods/Design

Reduce-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.

Discussion

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.

Trial registration

Clinicaltrials.gov: NCT01866800, 30 April 30 2013.