L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects

Inclusion Criteria: * Subjects, parents, or legal guardian of the subject who are willing and able to sign informed consent * Male and female subjects aged ≤18 years of age * Infants, children and adolescents undergoing cardiopulmonary bypass (CPB) for repair of a large unrestrictive VSD, an ostium primum ASD, or a partial or complete AVSD * Pre-operative echocardiogram which confirms the cardiovascular anatomy and defect to be surgically repaired Exclusion Criteria: * Evidence of pulmonary artery or vein abnormalities on the pre-operative echocardiogram that will not be addressed surgically. Specific abnormalities excluded include the following: * Significant pulmonary artery narrowing not amenable to surgical correction * Previous pulmonary artery stent placement * Significant left sided AV valve regurgitation not amenable to surgical correction * Pulmonary venous return abnormalities not amenable to surgical correction * Pulmonary vein stenosis not amenable to surgical correction * Preoperative requirement for mechanical ventilation or intravenous inotrope support * Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome) prior to surgical repair * Pre-operative use of medications to treat pulmonary hypertension * Pregnancy; Females of child-bearing potential must be willing to participate an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device) …