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

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Anesthesia and Intensive Care, Policlinico Universitario "Magna Grecia," Catanzaro, Italy. Cardiac Anesthesia and Intensive Care Unit, Monaldi Hospital A.O.R.N. "Dei Colli", Naples, Italy. Department of Anaesthesia and Critical Care Medicine, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. Department of Anaesthesia and Critical Care Medicine, Città della Salute e della Scienza, Torino, Italy. Clinic of Anesthesiology and Intensive Care Medicine, University Hospital Dubrava, Zagreb, Croatia. Anesthesiology & Intensive Care Department Moscow Regional Clinical & Research Institute, Moscow, Russia. Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy. Department of Intensive Care, Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia. Anesthesia and Intensive Care, A.O.U. IRCSS IST San Martino, Genova, Italy. Cardiac Anesthesia and Intensive Care, Ospedale Civile SS. Annunziata, Sassari, Italy. Anesthesia and Intensive Care, Azienda Ospedaliera Universitaria Santa Maria della Misericordia, Udine, Italy. Department of Cardiac Surgery, Ospedale S.Bortolo, Vicenza, Italy. Department of Anesthesia and Critical Care, AORN "Dei Colli", Naples, Italy. Anesthesia and Intensive Care, S.Orsola-Malpighi University Hospital, Bologna, Italy. Anesthesia and Intensive Care, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy. Anesthesia and Intensive Care, Azienda Ospedaliera Spedali Civili, Brescia, Italy. Departement of Cardiovascular Anaesthesia and Intensive Care, Azienda Ospedaliera S. Carlo, Potenza, Italy. Anesthesia and Intensive Care, Ospedale S. Gerardo, Monza, Italy. Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. Anesthesia and Intensive Care, Azienda Ospedaliera Papardo-Piemonte, Messina, Italy. Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy. Division of Cardiology, Medstar Washington Hospital Center, Washington DC. Department of Anesthesiology and Intensive Care, State Research Institute of Circulation Pathology, Novosibirsk, Russia. Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.

American heart journal. 2016;:66-73
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Abstract

OBJECTIVE Patients 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. DESIGN Double-blind, placebo-controlled, multicenter randomized trial. SETTING Tertiary care hospitals. INTERVENTIONS Cardiac 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 RESULTS The 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. CONCLUSIONS This 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.

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