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      Levosimendan for Hemodynamic Support after Cardiac Surgery.

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      The New England journal of medicine
      New England Journal of Medicine (NEJM/MMS)

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          Abstract

          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.

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          Most cited references20

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          Interval estimation for the difference between independent proportions: comparison of eleven methods

          Several existing unconditional methods for setting confidence intervals for the difference between binomial proportions are evaluated. Computationally simpler methods are prone to a variety of aberrations and poor coverage properties. The closely interrelated methods of Mee and Miettinen and Nurminen perform well but require a computer program. Two new approaches which also avoid aberrations are developed and evaluated. A tail area profile likelihood based method produces the best coverage properties, but is difficult to calculate for large denominators. A method combining Wilson score intervals for the two proportions to be compared also performs well, and is readily implemented irrespective of sample size.
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            Cardiogenic shock: current concepts and improving outcomes.

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              Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial.

              Because acute decompensated heart failure causes substantial morbidity and mortality, there is a need for agents that at least improve hemodynamics and relieve symptoms without adversely affecting survival. To assess the effect of a short-term intravenous infusion of levosimendan or dobutamine on long-term survival. The Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) study was a randomized, double-blind trial comparing the efficacy and safety of intravenous levosimendan or dobutamine in 1327 patients hospitalized with acute decompensated heart failure who required inotropic support. The trial was conducted at 75 centers in 9 countries and patients were randomized between March 2003 and December 2004. Intravenous levosimendan (n = 664) or intravenous dobutamine (n = 663). All-cause mortality at 180 days. All-cause mortality at 180 days occurred in 173 (26%) patients in the levosimendan group and 185 (28%) patients in the dobutamine group (hazard ratio, 0.91; 95% confidence interval, 0.74-1.13; P = .40). The levosimendan group had greater decreases in B-type natriuretic peptide level at 24 hours that persisted through 5 days compared with the dobutamine group (P<.001 for all time points). There were no statistical differences between treatment groups for the other secondary end points (all-cause mortality at 31 days, number of days alive and out of the hospital, patient global assessment, patient assessment of dyspnea at 24 hours, and cardiovascular mortality at 180 days). There was a higher incidence of cardiac failure in the dobutamine group. There were higher incidences of atrial fibrillation, hypokalemia, and headache in the levosimendan group. Despite an initial reduction in plasma B-type natriuretic peptide level in patients in the levosimendan group compared with patients in the dobutamine group, levosimendan did not significantly reduce all-cause mortality at 180 days or affect any secondary clinical outcomes. clinicaltrials.gov Identifier: NCT00348504.
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                Author and article information

                Journal
                N. Engl. J. Med.
                The New England journal of medicine
                New England Journal of Medicine (NEJM/MMS)
                1533-4406
                0028-4793
                May 25 2017
                : 376
                : 21
                Affiliations
                [1 ] From the Department of Anesthesia and Intensive Care, San Raffaele Scientific Institute (G.L., M.G.C., F.P., F.M., R. Lembo, A.M.S., T.B., A. Belletti, A.Z.), and Vita-Salute San Raffaele University (G.L., A.Z.), Milan, the Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Mater Domini Germaneto, Catanzaro (G.A., B.A., M.G.M.), the Department of Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza (R. Lobreglio, L.B.), the Department of Cardiovascular Anesthesia and Intensive Care, Azienda Ospedaliera Ordine Mauriziano (A. Bianchi), and the Department of Surgical Sciences, University of Turin (L.B.), Turin, the Division of Cardiac Anesthesia and Intensive Care Unit, Azienda Ospedaliera di Rilievo Nazionale dei Colli-Monaldi Hospital, Naples (A.P., L.V.), Division of Cardiothoracic and Vascular Anesthesia and Intensive Care, the Department of Anesthesia and Critical Care Medicine, Azienda Ospedaliero-Universitaria Pisana, Pisa (F.G., P.B.), and the Department of Cardiothoracic and Vascular Anesthesia and Intensive Care, University Hospital Policlinico S. Orsola, Bologna (M.B.) - all in Italy; the Department of Anesthesiology and Intensive Care, State Research Institute of Circulation Pathology, Novosibirsk (V.V. Lomivorotov, V.A.B., M.N.A.), the Department of Anesthesiology and Intensive Care, State Research Institute for Complex Issues of Cardiovascular Disease, Kemerovo (E.V.G., D.L.S.), the Department of Anesthesiology and Intensive Care, Moscow Regional Clinical and Research Institute, Moscow (V.V. Likhvantsev, T.S.Z.), and the Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan (V.V.P.) - all in Russia; Federal University of Juiz de Fora, Juiz de Fora, Brazil (M.F.S.-F.); and the University of Melbourne, Melbourne, VIC, Australia (R.B.).
                Article
                10.1056/NEJMoa1616325
                28320259
                678b6083-1b18-4383-bfb9-2e0b59b1e5b3
                History

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