Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery Following Fontan Surgery: a Randomized, Double-blind, Placebo-controlled Clinical Trial
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02115 |
| Conditions: |
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Heart Defects, Congenital |
| Purpose: |
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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.
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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Patients undergoing an elective, primary Fontan operation at Children's Hospital
Boston.
Exclusion Criteria:
- Revision surgery for failing Fontan circulation.
- Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.
- The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a
compelling indication to initiate either nesiritide or milrinone outside of the
confines of the study.
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| NCT ID: |
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NCT00543309 |
| Primary Contact: |
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Principal Investigator
John M Costello, MD MPH
Children's Hospital Boston
John M Costello, MD MPH
Phone: 617-355-4201
Email: jmcostello@childrensmemorial.org
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| Backup Contact: |
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Email: carolyn.dunbar-masterson@cardio.chboston.org
Carolyn Dunbar-Masterson, RN
Phone: 617-355-4201
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| Location Contact: |
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Boston, Massachusetts 02115
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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