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Phase 1 study of two inodilators in neonates undergoing cardiovascular surgery.
MedLine Citation:
PMID:  23138399     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background:Inodilators are routinely used in cardiovascular surgery with cardiopulmonary bypass (CPB). Information regarding safety and tolerability of the novel molecule, levosimendan, in newborns is anecdotal; no pharmacokinetic data in this population are available.Methods:Phase I, randomised, blind study. Neonates undergoing surgical repair for congenital heart defects received step-wise dose increases of milrinone (0.5- 1μg/kg per min, n=9) or levosimendan (0.1- 0.2μg/kg per min, n=11) as an i.v. continuous infusion, starting before CPB. Infants had continuous, time-locked, physiological and NIRS (cerebral and peripheral) recordings during the first 24 h, and at 48 h and 96 h post-surgery. Serial biochemistry and pharmacokinetic studies were performed.Results:During the first 24 h post-surgery, patients showed time-related, group-independent increased cerebral tissue oxygenation and decreased diastolic blood pressure; in addition, group-dependent differences in heart rate and peripheral perfusion were found. Early post-surgery, milrinone infants showed lower pH, higher glycaemia and higher inotrope score. The groups differed in cerebral NIRS-derived variables from 24 h to 96 h. Study drug withdrawal at 96 h was more frequent with levosimendan. Levosimendan intermediate metabolites were detected in plasma at day 14 post-surgery.Conclusion:Levosimendan is well tolerated in critically-ill neonates. Levosimendan may have advantages over milrinone in terms of the dosing regimen.Pediatric Research (2012); doi:10.1038/pr.2012.154.
Authors:
Adelina Pellicer; Joan Riera; Paloma Lopez-Ortego; María Carmen Bravo; Rosario Madero; Jesús Perez-Rodriguez; Carlos Labrandero; Jose Quero; Antonio Buño; Luis Castro; Rubin Lubomirov; Fernando Cabañas
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-08
Journal Detail:
Title:  Pediatric research     Volume:  -     ISSN:  1530-0447     ISO Abbreviation:  Pediatr. Res.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0100714     Medline TA:  Pediatr Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Neonatology, La Paz University Hospital, Madrid, Spain.
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