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
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
In brief
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.
Key facts
- Study ID
- NCT05253209
- Run by
- Asklepion Pharmaceuticals, LLC
- People needed
- 64
- Starts
- 2022-06-29
- Expected to finish
- 2024-05-10
- Last updated by the study team
- 2024-09-19
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's of Alabama — Birmingham, Alabama, United States
- Children's Hospital of Colorado — Aurora, Colorado, United States
- Heart Center, Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
- Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
- Duke University Medical Center Surgical Office of Clinical Research (SOCR) — Durham, North Carolina, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Nationwide Children's Hospital- The Heart Center — Columbus, Ohio, United States
- Seattle Children's Research Institute — Seattle, Washington, United States
- University of Wisconsin-Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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