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

Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradić, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Лихванцев, В. В.; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, B; Monaco, Fabrizio; Vuono, G. De; 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, Martina; Biondi‐Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J.; Lomivorotov, Vladimir V.; Landoni, Giovanni

doi:10.1016/j.ahj.2016.03.021

Cited by 22 publications

(6 citation statements)

References 36 publications

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“…Details of the statistical analysis plan have been published previously. 15 Primary analyses comparing levosimendan with placebo were performed according to the intention-to-treat principle. No imputation for missing data was applied.…”

Section: Discussionmentioning

confidence: 99%

“…Details of the trial methods and statistical analysis plan have been published previously. 15 The trial was funded by the Italian Ministry of Health and received a start-up grant from the European Association of Cardiothoracic Anesthesiologists. Levosimendan was provided free of charge by the manufacturer (Orion) to centers that recruited patients in Italy; all the centers in Russia and Brazil purchased the drug at full cost.…”

Section: Trial Designmentioning

confidence: 99%

“…Prespecified secondary outcomes were the following: acute kidney injury, 17 a need for renal-replacement therapy, a composite outcome of death and need for renal-replacement therapy, duration of mechanical ventilation, and durations of stay in the ICU and hospital. 15 We also collected data on the following outcomes: need for advanced mechanical circulatory support, myocardial infarction, type 1 or type 2 neurologic damage, 18 need for tracheostomy, sepsis, pneumonia, and mediastinitis. Definitions of the outcome measures are provided in the Supplementary Appendix.…”

Section: Outcome Measuresmentioning

confidence: 99%

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Levosimendan for Hemodynamic Support after Cardiac Surgery

Lomivorotov²,

et al. 2017

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Section: Discussionmentioning

confidence: 99%

Section: Trial Designmentioning

confidence: 99%

Section: Outcome Measuresmentioning

confidence: 99%

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Levosimendan for Hemodynamic Support after Cardiac Surgery

Lomivorotov²,

et al. 2017

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“…Levosimendan is characterised by a triple mechanism of action; i.e., it acts via calcium-dependent binding to cardiac troponin C, and opens the KATP channels on smooth muscle cells in the vasculature, and in cardiac mitochondria. This binding of levosimendan to troponin C and the opening of KATP channels on smooth muscle cells in the vessels result in its inotropic and vasodilatory effects, respectively, while the opening of KATP channels in cardiac mitochondria is believed to be a cardioprotective pathway (4). Levosimendan reduces peripheral vascular resistance and has direct contractility-enhancing effects on the failing left ventricle.…”

Section: Introductionmentioning

confidence: 99%

The role of levosimendan as inotropic agents in patients with LV dysfunction admitted to ICU post cardiac surgery

Hussein

Batah

Selit

et al. 2022

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BACKGROUND: Coronary artery bypass graft (CABG) surgery is the standard of care for the management of patients with three-vessel and left main coronary artery disease (CAD) with viable myocardium. Positive inotropic agents are the treatment of choice in patients with LV dysfunction post CABG. Levosimendan is an inotropic drug that has three major mechanisms of action: positive inotropy, vasodilation, and cardiac cytoprotection. Levosimendan is a calcium sensitizer, it improves myocardial contractility by sensitising troponin C to calcium without increasing myocardial oxygen consumption and without impairing relaxation and diastolic function. AIM: The aim of this study was to determine the effect of levosimendan compared to the conventional inotropic agents on the outcomes of patients with LV dysfunction undergoing CABG. METHODS: It is a prospective observational study that patients were divided into 2 groups of 50 patients each. Group A received intravenous levosimendan (at a dose of 0.2μg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1μg per kilogram per minute for 23 hours), with the infusion started at the induction of anesthesia while Group B which included patients who received conventional drugs. Clinical examination, Hemodynamic data and Laboratory investigations pre-operative and post-operative were collected.

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“…Pragmatic multicenter RCTs are currently considered the best available design to investigate the efficacy of treatments (19). Of note, all previous evidences on mortality reduction with levosimendan in septic and perioperative settings were based on small, single-center RCTs of moderate to low quality (16,22): we are waiting for the results of large ongoing perioperative multicenter RCTs (23)(24)(25) to see whether levosimendan is only an excellent inotropic drug or also has mortality reduction properties.…”

mentioning

confidence: 99%