John M Costello1, Carolyn Dunbar-Masterson2, Catherine K Allan2, Kimberlee Gauvreau2, Jane W Newburger2, Francis X McGowan2, David L Wessel2, John E Mayer2, Joshua W Salvin2, Roger E Dionne2, Peter C Laussen2. 1. From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children's Hospital, Harvard Medical School, MA; and Children's National Medical Center, George Washington University, Washington, DC (D.L.W.). jmcostello@luirechildrens.org. 2. From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children's Hospital, Harvard Medical School, MA; and Children's National Medical Center, George Washington University, Washington, DC (D.L.W.).
Abstract
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 thenesiritide, 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: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.
RCT Entities:
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: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.
Authors: Meena Nathan; Felicia L Trachtenberg; Maria I Van Rompay; William Gaynor; Kirk Kanter; Richard Ohye; Emile A Bacha; James Tweddell; Steven M Schwartz; L LuAnn Minich; Carlos M Mery; Steven D Colan; Jami Levine; Linda M Lambert; Jane W Newburger Journal: J Thorac Cardiovasc Surg Date: 2019-11-15 Impact factor: 5.209
Authors: Amee M Bigelow; Nancy S Ghanayem; Nathan E Thompson; John P Scott; Laura D Cassidy; Katherine J Woods; Ronald K Woods; Michael E Mitchell; Viktor Hraŝka; George M Hoffman Journal: Ann Thorac Surg Date: 2019-08-07 Impact factor: 5.102