Key result
Levosimendan improved cardiac output in 50% of interventions (p=0.004) in pediatric patients with refractory post-surgical low cardiac output syndrome, with no adverse effects observed.
Why the study?
Does levosimendan improve cardiac output in pediatric patients with refractory post-surgical low cardiac output syndrome?
Cohort (n=14)
Open-label
Does levosimendan improve cardiac output in pediatric patients with refractory post-surgical low cardiac output syndrome?
p-value: p=0.004
Levosimendan appears safe and effective for improving cardiac output and hemodynamic parameters in pediatric patients with refractory post-surgical low cardiac output syndrome.
May support levosimendan in refractory pediatric post-surgical LCOS; hypothesis-generating and requires RCTs before practice change.
INTRODUCTION: Low 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 METHODS: Open 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. RESULTS: LEVO 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. CONCLUSIONS: LEVO improved cardiac output in 50% of the interventions with post-surgical LCOS and no adverse effect was observed.
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Magliola et al. (2009) conducted a cohort in refractory post-surgical low cardiac output syndrome (n=14). Levosimendan was evaluated on Clinical improvement of cardiac output (p=0.004). Levosimendan improved cardiac output in 50% of interventions (p=0.004) in pediatric patients with refractory post-surgical low cardiac output syndrome, with no adverse effects observed.
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