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Sponsors and Collaborators: |
Children's Hospital Boston American Heart Association |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00543309 |
The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to separate the systemic and pulmonary circulations. Although mortality following the Fontan operation is now uncommon, early postoperative morbidity including prolonged postoperative chest tube drainage and hospitalization remains significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory therapies in the perioperative period is unknown and practice varies widely between centers.
The investigators will propose a single-center, randomized, double-blind, phase II clinical trial in children undergoing Fontan surgery. The investigators plan to compare the effects of perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical course and neurohumoral profile. The investigators hypothesize that, when compared to the milrinone and placebo groups, the nesiritide group will have more days alive and out of the hospital within the first 30 days after surgery.
Condition | Intervention | Phase |
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Heart Defects, Congenital |
Drug: nesiritide Drug: milrinone Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery Following Fontan Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
Estimated Enrollment: | 117 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental |
Drug: nesiritide
Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted
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II: Active Comparator |
Drug: milrinone
Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted
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III: Placebo Comparator |
Drug: placebo
Placebo bolus on CPB, then placebo infusion
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The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to separate the systemic and pulmonary circulations. Following this operation, deoxygenated blood flows passively from the body through the lungs without a pumping chamber. Although mortality following the Fontan operation is now uncommon, early postoperative morbidity including prolonged postoperative chest tube drainage and hospitalization remains significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory therapies in the perioperative period is unknown and practice varies widely between centers.
We propose a single-center, randomized, double-blind, phase II clinical trial in children undergoing Fontan surgery. We plan to compare the effects of perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical course and neurohumoral profile. The primary aim of the study is to determine whether nesiritide, milrinone or placebo infusion is associated with fewer days alive and out of the hospital within 30 days of surgery. We hypothesize that, when compared to the milrinone and placebo groups, the nesiritide group will have more days alive and out of the hospital within the first 30 days after surgery. Secondary aims are to determine the effects of these infusions on postoperative resource consumption, hemodynamics, arrhythmias, renal function, neurohumoral activation and adverse events. Thirty-nine patients per group (117 total patients) will be enrolled over three years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John M Costello, MD | 617-355-7866 | john.costello@cardio.chboston.org |
Contact: Ellen McGrath, RN | 617-355-5486 | ellen.mcgrath@cardio.chboston.org |
United States, Massachusetts | |
Children's Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: John M Costello, MD |
Principal Investigator: | John M Costello, MD | Children's Hospital Boston |
Responsible Party: | Children's Hospital, Boston ( John M. Costello, MD MPH ) |
Study ID Numbers: | 0735070N |
Study First Received: | October 10, 2007 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00543309 |
Health Authority: | United States: Food and Drug Administration |
Fontan Operation Cardiopulmonary Bypass Heart Defects, Congenital Milrinone Natriuretic peptide, brain |
Natriuretic Peptide, Brain Heart Diseases Cardiovascular Abnormalities |
Milrinone Congenital Abnormalities Heart Defects, Congenital |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Hematologic Agents Enzyme Inhibitors Cardiovascular Agents |
Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors |