Document Detail


Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease.
MedLine Citation:
PMID:  12600913     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Low cardiac output syndrome (LCOS), affecting up to 25% of neonates and young children after cardiac surgery, contributes to postoperative morbidity and mortality. This study evaluated the efficacy and safety of prophylactic milrinone in pediatric patients at high risk for developing LCOS. METHODS AND RESULTS: The study was a double-blind, placebo-controlled trial with 3 parallel groups (low dose, 25- microg/kg bolus over 60 minutes followed by a 0.25- microg/kg per min infusion for 35 hours; high dose, 75- microg/kg bolus followed by a 0.75- microg/kg per min infusion for 35 hours; or placebo). The composite end point of death or the development of LCOS was evaluated at 36 hours and up to 30 days after randomization. Among 238 treated patients, 25.9%, 17.5%, and 11.7% in the placebo, low-dose milrinone, and high-dose milrinone groups, respectively, developed LCOS in the first 36 hours after surgery. High-dose milrinone significantly reduced the risk the development of LCOS compared with placebo, with a relative risk reduction of 55% (P=0.023) in 238 treated patients and 64% (P=0.007) in 227 patients without major protocol violations. There were 2 deaths, both after infusion of study drug. The use of high-dose milrinone reduced the risk of the LCOS through the final visit by 48% (P=0.049). CONCLUSIONS: The use of high-dose milrinone after pediatric congenital heart surgery reduces the risk of LCOS.
Authors:
Timothy M Hoffman; Gil Wernovsky; Andrew M Atz; Thomas J Kulik; David P Nelson; Anthony C Chang; James M Bailey; Akbar Akbary; John F Kocsis; Raymond Kaczmarek; Thomas L Spray; David L Wessel
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Circulation     Volume:  107     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-02-25     Completed Date:  2003-03-12     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  996-1002     Citation Subset:  AIM; IM    
Affiliation:
Children's Hospital of Philadelphia, Philadelphia, Pa 19104, USA.
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MeSH Terms
Descriptor/Qualifier:
Blood Pressure
Cardiac Output, Low / prevention & control*
Child
Child, Preschool
Double-Blind Method
Endpoint Determination
Female
Heart Defects, Congenital / drug therapy*,  mortality,  surgery*
Humans
Infant
Infant, Newborn
Lactic Acid / blood
Male
Milrinone / adverse effects*,  therapeutic use*
Oxygen / blood
Syndrome
Chemical
Reg. No./Substance:
50-21-5/Lactic Acid; 7782-44-7/Oxygen; 78415-72-2/Milrinone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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