Levosimendan infusion in newborns after corrective surgery for congenital heart disease: Randomized controlled trial

Purpose: To evaluate the safety and efficacy of levosimendan in neonates with congenital heart disease undergoing cardiac surgery with cardiopulmonary bypass (CPB). Methods: Neonates undergoing risk-adjusted classification for congenital heart surgery (RACHS) 3 and 4 procedures were randomized to receive either a 72 h continuous infusion of 0.1 μg/kg/min levosimendan or standard post-CPB inotrope infusion. Results: Sixty-three patients (32 cases and 31 controls) were recruited. There were no differences between groups regarding demographic and baseline clinical data. No side effects were observed. There were no significant differences in mortality (1 vs. 3 patients, p = 0.35), length of mechanical ventilation (5.9 ± 5 vs. 6.9 ± 8 days, p = 0.54), and pediatric cardiac intensive care unit (PCICU) stay (11 ± 8 vs. 14 ± 14 days, p = 0.26). Low cardiac output syndrome occurred in 37 % of levosimendan patients and in 61 % of controls (p = 0.059, OR 0.38, 95 % CI 0.14-1.0). Postoperative heart rate, with a significant difference at 6 (p = 0.008), 12 (p = 0.037), and 24 h (p = 0.046), and lactate levels, with a significant difference at PCICU admission (p = 0.015) and after 6 h (p = 0.048), were lower in the levosimendan group. Inotropic score was significantly lower in the levosimendan group at PCICU admission, after 6 h and after 12 h, (p <0.0001). According to multivariate analysis, a lower lactate level 6 h after PCICU admission was independently associated with levosimendan administration after correction for CPB time and the need for deep hypothermic circulatory arrest. Conclusions: Levosimendan infused in neonates undergoing cardiac surgery was well tolerated with a potential benefit of levosimendan on postoperative hemodynamic and metabolic parameters of RACHS 3-4 neonates.