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Arch Argent Pediatr · Apr 2009
Clinical Trial[Levosimendan, a new inotropic drug: experience in children with acute heart failure].
- Ricardo Magliola, Guillermo Moreno, Juan C Vassallo, Luis M Landry, María Althabe, María Balestrini, Alberto Charroqui, Gladys Salgado, Evangelina Lataza, and Anthony C Chang.
- Unidad de Cuidados Intensivos UCI 35, Recuperación Cardiovascular, Hospital Nacional de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.
- Arch Argent Pediatr. 2009 Apr 1;107(2):139-45.
IntroductionLow cardiac output syndrome occurs frequently in pediatric patients after cardiac surgery. Catecholamines are used as inotropic drugs to treat this threatening condition, but may cause undesirable and potentially harmful side effects. This study was performed to evaluate the efficacy and safety of levosimendan (LEVO) in pediatric patients with low cardiac output syndrome.Patients And MethodsOpen prospective, quasi-experimental cohort. LEVO was given as compassionate treatment in patients with refractory post-surgical low cardiac output syndrome. Every patient received an IV infusion of LEVO at 6 microg/kg during a fifteen minutes period, followed by a 24 h IV infusion at 0.1 microg/kg/min. Clinical improvement of cardiac output was the primary end point of the study. Two independent observers performed clinical evaluation, bidimensional echocardiogram, hemodynamic and laboratory tests were performed pre and after LEVO infusion.ResultsLEVO was infused in 18 opportunities (fourteen children). The response was considered successful in 9/18 interventions (50%; p= 0.004). Both inotropic score (12.1 vs. 6,1, p= 0.01) and A-VDO(2)2 (26.78 +/- 11.5% vs. 20.81 +/- 7.72%, p= 0.029) showed reduction, while SvO2 improved (69.5 +/- 11.4% vs. 76 +/- 9.29%, p= 0.03). No adverse effects were noticed. Four patients died, none of them related to LEVO administration.ConclusionsLEVO improved cardiac output in 50% of the interventions with post-surgical LCOS and no adverse effect was observed.
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