Status:
WITHDRAWN
Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow
Lead Sponsor:
University of California, San Francisco
Conditions:
Heart Septal Defects, Ventricular
Atrioventricular Septal Defect
Eligibility:
All Genders
2-12 years
Phase:
PHASE1
Brief Summary
Infants with congenital heart disease and increased pulmonary blood flow have altered carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment will attenuate these al...
Detailed Description
AIM: To pilot a trial assessing the safety and pharmacokinetics (PK) of perioperative IV L-carnitine administration in these patients. To this end, a pilot clinical trial is proposed. Infants with VSD...
Eligibility Criteria
Inclusion
- have unrestrictive VSD, AVSD
- are undergoing complete repair
- are between 2-12 months of age
- are corrected gestational age ≥34 weeks
- will have an indwelling arterial or venous line
- have not had enteral or parenteral nutrition for at least 6 hrs
Exclusion
- have body weight \< 2.0 kg
- pulmonary artery or vein abnormalities not being addressed surgically
- suspected or proven in-born error of metabolism
- have other major congenital abnormalities that affect the cardiopulmonary system
- are taking carnitine supplementation
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01825369
Start Date
December 1 2014
End Date
July 1 2020
Last Update
May 6 2020
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143-0106