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.
Author(s): Arbel Y, Ben-Assa E(1), Halkin A, Keren G, Schwartz AL, Havakuk O, Leshem-Rubinow
E, Konigstein M, Steinvil A, Abramowitz Y, Finkelstein A, Banai S.
Affiliation(s): Author information:
(1)Department of Cardiology, Tel-Aviv Medical Center affiliated to the Sackler
Faculty of Medicine, Tel-Aviv University, 6 Weizman Street, Tel Aviv, Israel.
eyalbe@tlvmc.gov.il.
Publication date & source: 2014, Trials. , 15:262
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.
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