Phase 3Completed
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Subjects Undergoing Surgery for Congenital Heart Defects
- Sponsor
- Asklepion Pharmaceuticals, LLC (Industry)
- Enrollment
- 189 enrolled
- Conditions
- Acute Lung Injury
- Interventions
- L-citrulline; Placebo
- Ages
- children, adults
- Registry
- NCT02891837, EUCTR2016-002427-28
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- A Composite Variable Consisting of the Longer of Either (1) Length of Time on Mechanical Ventilation or (2) Length of Inotrope Use.
History
Results first posted
Last registry update
Study completion
Primary completion
Registered
Started