Status:
TERMINATED
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
Lead Sponsor:
Asklepion Pharmaceuticals, LLC
Conditions:
Ventricular Septal Defect
Atrioventricular Septal Defect
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief 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....
Detailed Description
This is a randomized, double-blind, placebo controlled, multicenter study that will compare the efficacy and safety of L- citrulline versus placebo in patients undergoing surgery for congenital heart ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05253209
Start Date
June 29 2022
End Date
May 10 2024
Last Update
September 19 2024
Active Locations (10)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
3
Heart Center, Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611-2605
4
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202