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

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asklepion Pharmaceuticals, LLC

Criteria

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 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)

• Any condition which, in the opinion of the investigator, might interfere with the study objectives

• 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