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

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Asklepion Pharmaceuticals, LLC
• Treatments: Plasma-lyte 148

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:

• 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