• Tiziana Bove, Alberto Zangrillo, Fabio Guarracino, Gabriele Alvaro, Bruno Persi, Enivarco Maglioni, Nicola Galdieri, Marco Comis, Fabio Caramelli, Daniela C Pasero, Giovanni Pala, Massimo Renzini, Massimiliano Conte, Gianluca Paternoster, Blanca Martinez, Fulvio Pinelli, Mario Frontini, Maria C Zucchetti, Federico Pappalardo, Bruno Amantea, Annamaria Camata, Antonio Pisano, Claudio Verdecchia, Erika Dal Checco, Claudia Cariello, Luana Faita, Rubia Baldassarri, Anna M Scandroglio, Omar Saleh, Rosalba Lembo, Maria G Calabrò, Rinaldo Bellomo, and Giovanni Landoni.
• IRCCS San Raffaele Scientific Institute, Milan, Italy.
• JAMA. 2014 Dec 3;312(21):2244-53.

ImportanceNo effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery.ObjectiveTo determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury.Design, Setting, And ParticipantsMulticenter, randomized, double-blind, placebo-controlled, parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy. We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury (≥50% increase of serum creatinine level from baseline or oliguria for ≥6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). We used a computer-generated permuted block randomization sequence for treatment allocation. All patients completed their follow-up 30 days after surgery, and data were analyzed according to the intention-to-treat principle.InterventionsContinuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 μg/kg/min (range, 0.025-0.3 µg/kg/min).Main Outcomes And MeasuresThe primary end point was the rate of renal replacement therapy. Secondary end points included mortality (intensive care unit and 30-day mortality) and the rate of hypotension during study drug infusion.ResultsThe study was stopped for futility as recommended by the safety committee after a planned interim analysis. Sixty-nine of 338 patients (20%) allocated to the fenoldopam group and 60 of 329 patients (18%) allocated to the placebo group received renal replacement therapy (P = .47). Mortality at 30 days was 78 of 338 (23%) in the fenoldopam group and 74 of 329 (22%) in the placebo group (P = .86). Hypotension occurred in 85 (26%) patients in the fenoldopam group and in 49 (15%) patients in the placebo group (P = .001).Conclusions And RelevanceAmong patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension.Trial Registrationclinicaltrials.gov Identifier: NCT00621790.

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