Levosimendan Administration in Neonates With Transposition of the Great Arteries

Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial

Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the myocardial protection effect of peri-operative iv infusion of Levosimendan in a cohort of neonates affected by transposition of the great arteries undergoing surgical correction by arterial switch.

Function of the myocardium of neonates with congenital heart disease may be affected by several factors in post operative phase: congenital insufficiency, cardiopulmonary bypass low perfusion, ischemima during the cross-clamp phase, low cardiac output syndrome, systemic inflammation. Furthermore, neonates have immature molecular mechanisms leading to calcium utilization inside myocytes. Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the inodilator and myocardial protection effect of peri-operative iv infusion of 0.1 mcg/kg/min Levosimendan (without previuos bolus) in a cohort of neonates affected by transposition of the great arteries undergoing surgical correction by arterial switch.

levosimendan, pediatric cardiac surgery, low cardiac output syndrome, transposition of the great arteries

patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min

inotropic score will be calculated as: dopamine (mcg/Kg/min) * 1 + milrinone (mcg/Kg/min) * 15 + epinephrine (mcg/Kg/min) * 100.

Time points: from T0 (within 1 hour of intensive care unit admission) to T7 (72nd post operative hour) through T2, T3, T4, T5, T6, T7)

LCOS will be estimated by the analysis of average heart rate, mean arterial pressure, left atrial pressure, lactates and pH during the evaluated time frame

Time points: from T0 (within 1 hour of intensive care unit admission) to T7 (72nd post operative hour) through T2, T3, T4, T5, T6, T7)

Inclusion Criteria: neonates affected by transposition of the great arteries scheduled to elective surgery Exclusion Criteria: neonates affected by transposition of the great arteries who are not scheduled to elective surgery (urgent procedures, patients older than 30 days)

Di Chiara L, Ricci Z, Garisto C, Morelli S, Giorni C, Vitale V, Di Donato RM, Picardo S. Initial experience with levosimendan infusion for preoperative management of hypoplastic left heart syndrome. Pediatr Cardiol. 2010 Jan;31(1):166-7. doi: 10.1007/s00246-009-9571-6. No abstract available.

Osthaus WA, Boethig D, Winterhalter M, Huber D, Goerler H, Sasse M, Sumpelmann R. First experiences with intraoperative Levosimendan in pediatric cardiac surgery. Eur J Pediatr. 2009 Jun;168(6):735-40. doi: 10.1007/s00431-008-0834-7. Epub 2008 Sep 24.