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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 gases

Blood 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

Page last updated: August 23, 2015

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