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

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.