Clinical trial NCT01120106: Levosimendan Administration in Neonates With Transposition of the Great Arteries
Official title: Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Cardiac Output Syndrome
Keywords: levosimendan
pediatric cardiac surgery
low cardiac output syndrome
transposition of the great arteries
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2010-05-10
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: lower inotropic score in the levosimendan group
timeFrame: 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)
Secondary outcomes:
measure: Low cardiac output syndrome (LCOS) incidence reduction in the treatment group
timeFrame: 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)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital
Study officials:
affiliation: Bambino Gesù Hospital
name: Sergio Picardo, MD, Head
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.