A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design (CROSBI ID 229582)
Prilog u časopisu | izvorni znanstveni rad | međunarodna recenzija
Podaci o odgovornosti
Zangrillo, Alberto ; Alvaro, Gabriele ; Pisano, Antonio ; Guarracino, Fabio ; Lobreglio, Rosetta ; Bradić, Nikola ; Lembo, Rosalba ; Gianni, Stefano ; Calabrò, Maria Grazia ; Likhvantsev, Valery ; Grigoryev, Evgeny ; Buscaglia, Giuseppe ; Pala, Giovanni ; Auci, Elisabetta ; Amantea, Bruno ; Monaco, Fabrizio ; De Vuono, Giovanni ; Corcione, Antonio ; Galdieri, Nicola ; Cariello, Claudia ; Bove, Tiziana ; Fominskiy, Evgeny ; Auriemma, Stefano ; Baiocchi, Massimo ; Bianchi, Alessandro ; Frontini, Mario ; Paternoster, Gianluca ; Sangalli, Fabio ; Wang, Chew-Yin ; Zucchetti, Maria Chiara ; Biondi-Zoccai, Giuseppe ; Gemma, Marco ; Lipinski, Michael J. ; Lomivorotov, Vladimir ; Landoni, Giovanni
engleski
A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design
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.
Levosimendan ; High-risk Cardiac Surgery ; Myocardial Dysfunction
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Podaci o izdanju
177
2016.
66-73
objavljeno
0002-8703
10.1016/j.ahj.2016.03.021. Epub 2016 Apr 23
Povezanost rada
Temeljne medicinske znanosti, Kliničke medicinske znanosti