Document Detail

Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  24906491     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes.
METHODS AND RESULTS: In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0-24]; milrinone, 18 [0-23]; placebo, 20 [0-23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events.
CONCLUSIONS: Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery.
CLINICAL TRIAL REGISTRATION URL: Unique identifier: NCT00543309.
John M Costello; Carolyn Dunbar-Masterson; Catherine K Allan; Kimberlee Gauvreau; Jane W Newburger; Francis X McGowan; David L Wessel; John E Mayer; Joshua W Salvin; Roger E Dionne; Peter C Laussen
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2014-06-06
Journal Detail:
Title:  Circulation. Heart failure     Volume:  7     ISSN:  1941-3297     ISO Abbreviation:  Circ Heart Fail     Publication Date:  2014 Jul 
Date Detail:
Created Date:  2014-07-16     Completed Date:  2014-09-30     Revised Date:  2014-11-13    
Medline Journal Info:
Nlm Unique ID:  101479941     Medline TA:  Circ Heart Fail     Country:  United States    
Other Details:
Languages:  eng     Pagination:  596-604     Citation Subset:  IM    
Copyright Information:
© 2014 American Heart Association, Inc.
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MeSH Terms
Cardiotonic Agents / administration & dosage
Child, Preschool
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Follow-Up Studies
Fontan Procedure*
Heart Defects, Congenital / surgery
Heart Failure / physiopathology,  prevention & control*
Infusions, Intravenous
Length of Stay / trends
Milrinone / administration & dosage*
Natriuretic Peptide, Brain / administration & dosage*
Postoperative Care / methods*
Recovery of Function / drug effects*
Retrospective Studies
Time Factors
Treatment Outcome
Ventricular Function, Left / physiology*
Reg. No./Substance:
0/Cardiotonic Agents; 114471-18-0/Natriuretic Peptide, Brain; JU9YAX04C7/Milrinone

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