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

PHASE3TerminatedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 29, 2022

Primary Completion Date

May 10, 2024

Study Completion Date

May 10, 2024

Conditions
Ventricular Septal DefectAtrioventricular Septal DefectPrimum Atrial Septal Defect
Interventions
DRUG

L-citrulline

Intravenous L-citrulline given for up to 48 hours

DRUG

Plasmalyte A

Intravenous Plasmalyte A given for up to 48 hours

Trial Locations (10)

27710

Duke University Medical Center Surgical Office of Clinical Research (SOCR), Durham

35233

Children's of Alabama, Birmingham

43215

Nationwide Children's Hospital- The Heart Center, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

63104

Cardinal Glennon Children's Hospital, St Louis

80045

Children's Hospital of Colorado, Aurora

98105

Seattle Children's Research Institute, Seattle

60611-2605

Heart Center, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

53792-4108

University of Wisconsin-Madison, Madison

Sponsors
All Listed Sponsors
lead

Asklepion Pharmaceuticals, LLC

INDUSTRY