A 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

About this Study

This clinical trial is designed to determine how effictive  L-Citrulline is for pediatric patients with heart defects that will need surgery and the use of bypass during the surgery. The primary objective of the study will be to determine if L-Citrulline ,given during surgery, reduces lung injury in pediatric patients.

Sponsor Protocol ID:CIT-003-01
IRB Number:2017-0315
Closed for Enrollment
Phase 3
May 28, 2019
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Subjects or parents or legal guardian of the subject who are willing and able to sign consent. 
  • Male and female subjects aged ≤18 years of age. 
  • Infants, children and adolescents undergoing cardiopulmonary bypass 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

Exclusion Criteria
  • Pre-operative use of medications to treat pulmonary
  • 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.

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Heart Health
Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Contact Information
Contact Name: Angelena Sharp
Phone Number: 601-815-9282
Email: asharp@umc.edu
Principal Investigator:Taylor, Mary B, M.D.
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