A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects

About the study

This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Patients, parents, or legal guardian willing and able to sign informed consent
Male and female subjects aged ≤18 years of age (females of child-bearing potential willing to practice an acceptable form of birth control)
Patients undergoing cardiopulmonary bypass for repair of a large unrestrictive ventricular septal defect, an ostium primum/secundum atrial septal defect, or a partial or complete atrioventricular septal defect
Pre-operative echocardiogram confirming cardiovascular anatomy and defect to be repaired

EXCLUSION CRITERIA

Exclusion Criteria:

Evidence of pulmonary artery or vein abnormalities that will not be addressed surgically. Specific abnormalities excluded include:

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 IV 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; Sexually active females of child-bearing potential must be willing to practice an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device)
Participation in another clinical trial within 30 days of Screening or while participating in the current study, including the 28 days of follow-up post study drug administration.
Any condition which, in the opinion of the investigator, might interfere with the study objectives