Congenital heart defects are the most prevalent group of congenital malformations in
newborns. Surgery-related low cardiac output syndrome (LCOS) could be one of the reason for
the unfavourable outcome of this population. The early use of inodilators (INDs),
specifically milrinone (MR), is proposed to reduce afterload and increase inotropism. Studies
in the paediatric population appear to support a clinical usefulness of MR similar to that
observed in adults. Levosimendan (LEVO) is a novel class IND developed for the treatment of
heart failure. Experience with LEVO in paediatric patients is scarce. The purpose of this
study was to systematically test the efficacy and safety of milrinone (MR) and levosimendan
(LEVO) in newborns undergoing cardiovascular surgery with cardiopulmonary bypass (CPB). Given
the uncertainty about LEVO pharmacokinetics in neonates, the study was designed as a pilot,
phase I feasibility study.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Collaborators:
Fondo de Investigacion Sanitaria Hospital Universitario La Paz