A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design
| Autor: | Rosalba Lembo, Marco Gemma, Massimo Baiocchi, Giuseppe Biondi-Zoccai, Rosetta Lobreglio, Claudia Cariello, Giovanni De Vuono, Gianluca Paternoster, Fabrizio Monaco, Vladimir V. Lomivorotov, Alberto Zangrillo, Alessandro Bianchi, Evgeny Grigoryev, Maria Chiara Zucchetti, Valery Likhvantsev, Michael J. Lipinski, Tiziana Bove, Fabio Guarracino, Stefano Gianni, Antonio Pisano, Stefano Auriemma, Fabio Sangalli, Mario Frontini, Gabriele Alvaro, Maria Grazia Calabrò, Giovanni Landoni, Giovanni Pala, Nikola Bradic, Chew Yin Wang, Elisabetta Auci, Antonio Corcione, Evgeny Fominskiy, Nicola Galdieri, Bruno Amantea, Giuseppe Buscaglia |
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| Přispěvatelé: | Zangrillo, Alberto, Alvaro, G, Pisano, A, Guarracino, F, Lobreglio, R, Bradic, N, Lembo, R, Gianni, S, Calabrò, Mg, Likhvantsev, V, Grigoryev, E, Buscaglia, G, Pala, G, Auci, E, Amantea, B, Monaco, F, De Vuono, G, Corcione, A, Galdieri, N, Cariello, C, Bove, T, Fominskiy, E, Auriemma, S, Baiocchi, M, Bianchi, A, Frontini, M, Paternoster, G, Sangalli, F, Wang, Cy, Zucchetti, Mc, Biondi Zoccai, G, Gemma, M, Lipinski, Mj, Lomivorotov, Vv, Landoni, Giovanni |
| Rok vydání: | 2015 |
| Předmět: |
Infusions
Cardiac output medicine.medical_specialty Cardiotonic Agents Cardiac Output Low 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Postoperative Complications Randomized controlled trial Double-Blind Method law Internal medicine medicine Clinical endpoint Humans 030212 general & internal medicine Cardiac Output Cardiac Surgical Procedures Infusions Intravenous Simendan Intra-Aortic Balloon Pumping business.industry Respiration Hydrazones Levosimendan Perioperative Acute Kidney Injury Length of Stay Intensive care unit Respiration Artificial Low Cardiac surgery Pyridazines Intensive Care Units Artificial Cardiology and Cardiovascular Medicine Cardiology Intravenous business medicine.drug |
| Zdroj: | American heart journal. 177 |
| ISSN: | 1097-6744 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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