Abstract 12099: Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery Following Fontan Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Introduction: Nesiritide has vasodilatory, lusitropic and natriuretic properties and may decrease myocardial ischemia-reperfusion injury. Milrinone is an inodilator with lusitropic effects. Although such properties make both drugs attractive for perioperative use, their efficacy has not been prospectively studied in children undergoing a Fontan operation. We sought to determine whether empiric nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that when compared to milrinone or placebo, patients assigned to receive nesiritide would have more days alive and out of the hospital within the first 30 days after surgery.
Methods: In a single center, randomized, double-blinded, placebo-controlled clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone or placebo. A loading dose of study drug was administered in the operating room prior to the onset of rewarming from CPB, and a continuous infusion was then administered for at least 12 hours after CICU admission and up to five days. The primary outcome was the number of days alive and out of the hospital within 30 days of surgery (for this outcome, more days alive and out of the hospital is favorable). Secondary outcomes included measures of cardiac index, resource utilization, renal function, and adverse events.
Results: Among 106 enrolled subjects, 35, 36 and 35 were assigned to the nesiritide, milrinone, and placebo groups, respectively. Demographics, patient factors and operative characteristics 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 (range 0-24); milrinone, 18 (0-23); placebo, 20 (0-23); p = 0.38]. Treatment groups did not differ in postoperative cardiac index, hemodynamics, arrhythmias, peak lactate, inotropic scores, fluid balance, urine output, renal function, hours of mechanical ventilation, days of intensive care or chest tube drainage, or adverse events.
Conclusions: When compared to placebo, empiric perioperative infusions of nesiritide or milrinone are not associated with improved early clinical outcomes following Fontan surgery.
- Clinical trials
- Fontan physiology
- Natriuretic peptide
- Pediatric cardiac intensive care
- Congenital heart surgery
- © 2013 by American Heart Association, Inc.