Journal Article

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

Cogo, Paola E., Ricci, Zaccaria, Favia, Isabella, Vitale, Vincenzo, Garisto, Cristiana, Di Chiara, Luca

2012

Overview

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.

• Publisher: Springer-Verlag,Springer,Springer Nature B.V
• Subject: Acidosis / Analysis / Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy / Anesthesiology / Biological and medical sciences / Cardiac arrhythmia / Cardiac Output, Low - drug therapy / Cardiac Output, Low - etiology / Cardiac Output, Low - prevention & control / Cardiac Surgical Procedures - adverse effects / Cardiotonic Agents - administration & dosage / Cardiotonic Agents - therapeutic use / Cardiovascular disease / Children / Cisatracurium / Clinical trials / Congenital diseases / Congenital heart disease / Coronary artery bypass / Critical Care Medicine / Diseases / Drugs / Emergency Medicine / Genetic disorders / Health aspects / Heart beat / Heart Defects, Congenital - drug therapy / Heart Defects, Congenital - surgery / Heart diseases / Heart failure / Heart rate / Heart surgery / Hemodynamics / Humans / Hydrazones - administration & dosage / Hydrazones - therapeutic use / Infant, Newborn / Infants (Newborn) / Infusions, Intravenous / Intensive / Intensive care / Intensive care medicine / Italy / Medical sciences / Medicine / Medicine & Public Health / Metabolism / Mortality / Outcome Assessment (Health Care) / Oxygen saturation / Pain Medicine / Pediatric cardiology / Pediatric intensive care / Pediatric Original / Pediatrics / Pneumology/Respiratory System / Postoperative Complications - drug therapy / Postoperative Complications - epidemiology / Postoperative Complications - prevention & control / Pyridazines - administration & dosage / Pyridazines - therapeutic use / Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases / Surgery of the heart / Ventilators