Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow
Status:
Withdrawn
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Infants with congenital heart disease and increased pulmonary blood flow have altered
carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment
will attenuate these alterations and improve clinical outcomes.
The investigators will pilot a trial assessing the safety and pharmacokinetics of
perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical
trial is proposed. Infants with ventricular septal defects or atrioventricular septal defects
undergoing complete surgical repair will receive L-carnitine (25, 50, or 100 mg/kg, IV) just
prior to cardiopulmonary bypass (CPB) and 2hr after CPB. Carnitine levels will be measured
before CPB, and before and 0.5, 1.5, 3, 5, 9, 12, and 24h after the second dose. The safety,
pharmacokinetic profile, feasibility, and effect of L-carnitine administration on biochemical
parameters, as well as clinical outcomes will be determined. The investigators expect this
pilot to provide the data needed to proceed with a placebo-based randomized, controlled,
trial.