The effect of low-dose furosemide in critically ill patients with early acute kidney injury: a pilot randomized blinded controlled trial (the SPARK study)

Abstract

PURPOSE: Furosemide is commonly prescribed in acute kidney injury (AKI). Prior studies have found conflicting findings on whether furosemide modifies the course and outcome of AKI. METHODS: Pilot multi-center randomized blinded placebo-controlled trial in adult patients with AKI admitted to three intensive care units. Participants were randomly allocated to furosemide bolus and infusion or 0.9% saline placebo. Primary endpoint was worsening AKI, defined by the RIFLE criteria. Secondary endpoints were kidney recovery, renal replacement therapy (RRT) and adverse events. RESULTS: The trial was terminated after enrollment of 73 participants (37 to furosemide and 36 to placebo). Mean (SD) age was 61.7 (14.3), 79.5% were medical admissions, mean (SD) APACHE II score was 26.6 (7.8), 90.4% received mechanical ventilation and 61.6% received vasoactives. Groups were similar at baseline. No differences were found in the proportion with worsening AKI (43.2% vs. 37.1%, p=0.6), kidney recovery (29.7% vs. 42.9%, p=0.3), or RRT (27.0% s. 28.6%, p=0.8). Adverse events, mostly electrolyte abnormalities, were more common in furosemide-treated patients (p<0.001). Protocol deviations were common, due often to supplementary furosemide. CONCLUSIONS: In this pilot trial, furosemide did not reduce the rate of worsening AKI, improve recovery or reduce RRT; however, was associated with greater electrolyte abnormalities. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00978354 registered September 9, 2014.