101. Levosimendan for Hemodynamic Support after Cardiac Surgery
- Author
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Federico Pappalardo, Tatiana S. Zabelina, Vladimir A. Boboshko, Antonio Pisano, Fabio Guarracino, Vladimir V. Lomivorotov, Alessandro Belletti, Pietro Bertini, Vadim Pasyuga, Marcello Fonseca Salgado-Filho, Rosetta Lobreglio, Rosalba Lembo, Maria G Michienzi, Tiziana Bove, Anna Mara Scandroglio, Gabriele Alvaro, Massimo Baiocchi, Marat N Abubakirov, Bruno Amantea, Giovanni Landoni, Maria Grazia Calabrò, Luca Brazzi, Rinaldo Bellomo, Dmitriy L Shukevich, Evgeny Grigoryev, Alberto Zangrillo, Luigi Verniero, Valery Likhvantsev, Alessandro Bianchi, Fabrizio Monaco, Landoni, Giovanni, Lomivorotov, Vladimir V., Alvaro, Gabriele, Lobreglio, Rosetta, Pisano, Antonio, Guarracino, Fabio, Calabrò, Maria G., Grigoryev, Evgeny V., Likhvantsev, Valery V., Salgado Filho, Marcello F., Bianchi, Alessandro, Pasyuga, Vadim V., Baiocchi, Massimo, Pappalardo, Federico, Monaco, Fabrizio, Boboshko, Vladimir A., Abubakirov, Marat N., Amantea, Bruno, Lembo, Rosalba, Brazzi, Luca, Verniero, Luigi, Bertini, Pietro, Scandroglio, Anna M., Bove, Tiziana, Belletti, Alessandro, Michienzi, Maria G., Shukevich, Dmitriy L., Zabelina, Tatiana S., Bellomo, Rinaldo, and Zangrillo, Alberto
- Subjects
Male ,Cardiac output ,Cardiac Output, Low ,Hemodynamics ,030204 cardiovascular system & hematology ,law.invention ,Postoperative Complications ,0302 clinical medicine ,Randomized controlled trial ,law ,Cardiac Surgical Procedure ,Infusions, Intravenou ,Treatment Failure ,Cardiac Output ,Respiration ,Medicine (all) ,General Medicine ,Middle Aged ,Hydrazone ,Intensive care unit ,Aged ,Cardiotonic Agents ,Double-Blind Method ,Female ,Humans ,Hydrazones ,Infusions, Intravenous ,Length of Stay ,Perioperative Period ,Pyridazines ,Respiration, Artificial ,Stroke Volume ,Cardiac Surgical Procedures ,Mortality ,Low ,Cardiac surgery ,Artificial ,Cardiology ,Intravenous ,Pyridazine ,Human ,medicine.drug ,Infusions ,medicine.medical_specialty ,Placebo ,03 medical and health sciences ,Internal medicine ,medicine ,Cardiotonic Agent ,Hemodynamic ,business.industry ,030208 emergency & critical care medicine ,Perioperative ,Levosimendan ,Postoperative Complication ,business - Abstract
BACKGROUND Acute left ventricular dysfunction is a major complication of cardiac surgery and is associated with increased mortality. Meta-analyses of small trials suggest that levosimendan may result in a higher rate of survival among patients undergoing cardiac surgery. METHODS We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025 to 0.2 μg per kilogram of body weight per minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30-day mortality. RESULTS The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30-day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], -5.7 to 5.9; P = 0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, -2 hours; 95% CI, -5 to 1; P = 0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, -12 hours; 95% CI, -21 to 2; P = 0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, -1 to 2; P = 0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias. CONCLUSIONS In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo. (Funded by the Italian Ministry of Health; CHEETAH ClinicalTrials.gov number, NCT00994825.).
- Published
- 2017
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