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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Lung Injury

In brief

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.

Key facts

Study ID

NCT02891837

Run by

Asklepion Pharmaceuticals, LLC

People needed

189

Starts

2016-08-01

Expected to finish

2019-07-01

Last updated by the study team

2023-02-23

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Loma Linda University Children's Hospital — Loma Linda, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Advocate Children's Hospital — Oak Lawn, Illinois, United States
• Riley Hospital for Children at Indiana University — Indianapolis, Indiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St Louis University, SSM Health Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
• Washington University School of Medicine/ St Louis Children's Hospital — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• LKH-Universitätsklinikum Graz Universitätsklinik für Kinder- und Jugendheilkunde — Graz, Austria
• Medizinische Universität Wien, Klinik für Kinder- und Jugendheilkunde, Abteilung für Pädiatrische Kardiologie Kinderherzzentrum — Vienna, Austria
• Universitätsmedizin Göttingen — Göttingen, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Klinik für Kinderkardiologie und angeborene Herzfehler. Deutsches Herzzentrum München - Klinik an der TU München — München, Germany

Full record on ClinicalTrials.gov

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