• American heart journal · Jul 2016

    Randomized Controlled Trial Multicenter Study

    A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

    • Alberto Zangrillo, Gabriele Alvaro, Antonio Pisano, Fabio Guarracino, Rosetta Lobreglio, Nikola Bradic, Rosalba Lembo, Stefano Gianni, Maria Grazia Calabrò, Valery Likhvantsev, Evgeny Grigoryev, Giuseppe Buscaglia, Giovanni Pala, Elisabetta Auci, Bruno Amantea, Fabrizio Monaco, Giovanni De Vuono, Antonio Corcione, Nicola Galdieri, Claudia Cariello, Tiziana Bove, Evgeny Fominskiy, Stefano Auriemma, Massimo Baiocchi, Alessandro Bianchi, Mario Frontini, Gianluca Paternoster, Fabio Sangalli, Chew-Yin Wang, Maria Chiara Zucchetti, Giuseppe Biondi-Zoccai, Marco Gemma, Michael J Lipinski, Vladimir V Lomivorotov, and Giovanni Landoni.
    • Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Anesthesia and Intensive Care, Policlinico Universitario "Magna Grecia," Catanzaro, Italy.
    • Am. Heart J. 2016 Jul 1; 177: 66-73.

    ObjectivePatients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.DesignDouble-blind, placebo-controlled, multicenter randomized trial.SettingTertiary care hospitals.InterventionsCardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours.Measurements And Main ResultsThe primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.ConclusionsThis trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.Copyright © 2016 Elsevier Inc. All rights reserved.

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