Two Inodilators Postsurgery in Neonates
Information source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Cardiac Output Syndrome
Intervention: Milrinone (Drug); Levosimendan (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz Official(s) and/or principal investigator(s): Adelina Pellicer, PhD, Principal Investigator, Affiliation: Dept. of Neonatology, La Paz University Hospital, Madrid Joan Riera, MBE, Study Chair, Affiliation: Bio-Engineer and Nanotechnology Dept., Polytechnic University of Madrid Paloma López, MD, Study Chair, Affiliation: Dept. of Neonatology, La Paz University Hospital, Madrid María Carmen Bravo, PhD, Study Chair, Affiliation: Dept. of Neonatology, La Paz University Hospital, Madrid Rosario Madero, MD, Study Chair, Affiliation: Division of Biostatistics, La Paz University Hospital, Madrid Jesús Pérez-Rodríguez, PhD, Study Chair, Affiliation: Dept. of Neonatology, La Paz University Hospital, Madrid Carlos Labrandero, MD, Study Chair, Affiliation: Dept. Paediatric Cardiology, La Paz University Hospital, Madrid José Quero, PhD, Study Chair, Affiliation: Dept. of Neonatology, La Paz University Hospital, Madrid Antonio Buño, PhD, Study Chair, Affiliation: Clinical Pathology Service, La Paz University Hospital, Madrid Luis Castro, MD, Study Chair, Affiliation: Dept. Paediatric Anaesthesiology, La Paz University Hospital, Madrid Fernando Cabañas, PhD, Study Chair, Affiliation: Dept. of Neonatology, La Paz University Hospital, Madrid
Summary
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.
Clinical Details
Official title: Phase I Study of Two Inodilators in Neonates Undergoing Cardiovascular Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Perfusion-oxygenation
Secondary outcome: Blood gasesBlood pressure temperature arterial oxygen saturation cooximetry lactate glucose haemoglobin concentration Biochemical markers Inodilators concentration inotrope score
Detailed description:
Surgical repair is the primary therapy for congenital heart defects in the newborn. The
neonatal cardiovascular system is at particular risk to develop the surgery-related low
cardiac output syndrome (LCOS), thus vasoactive agents are routinely used in the
postoperative management. Systematic research on the efficacy of these drugs is scarce in
the newborn. As LCOS pathophysiology joints impaired myocardial contractility and the
peripheral effects of ischemia/reperfusion injury on the endothelium, early use of
inodilators (IND) are strongly recommended to reduce afterload and improve contractility.
This study aims to test the equivalence in dose-dependent hemodynamic effects of 2 IND,
Milrinone and Levosimendan, used early without loading dose in the preoperative period to
prevent LCOS. By means of non-invasive technology the investigators will assess cardiac
function (serial structural and functional echocardiography), the cerebral and peripheral
perfusion and oxygenation (continuous near-infrared monitoring), cerebral function
(continuous amplitude integrated EEG monitoring), will rule out CNS acquired lesions
(serial transfontanelar echo-Doppler studies), and will follow up different biochemical
markers of myocardial stress and apoptosis. Pharmacokinetic studies will be also performed.
Eligibility
Minimum age: N/A.
Maximum age: 40 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Newborns undergoing cardiovascular surgery who were in stable pre-operative
haemodynamic condition
- Parental consent given
Exclusion Criteria:
- Parental consent refused
- Inodilators contraindicated
Locations and Contacts
Hospital Universitario La Paz, Madrid 28046, Spain
Additional Information
Related publications: Bravo MC, López P, Cabañas F, Pérez-Rodríguez J, Pérez-Fernández E, Quero J, Pellicer A. Acute effects of levosimendan on cerebral and systemic perfusion and oxygenation in newborns: an observational study. Neonatology. 2011;99(3):217-23. doi: 10.1159/000314955. Epub 2010 Sep 25. Erratum in: Neonatology. 2011;99(4):301. Bravo, María del Carmen [corrected to Bravo, María Carmen]; Quero, José [added].
Starting date: November 2009
Last updated: April 11, 2012
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