Status:
COMPLETED
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
Lead Sponsor:
Asklepion Pharmaceuticals, LLC
Collaborating Sponsors:
Vanderbilt University
Conditions:
Heart Defects, Congenital
Hypertension, Pulmonary
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned t...
Detailed Description
Increased pulmonary vascular tone (PVT) can complicate the postoperative course of the following five surgical procedures for congenital heart defects: 1) unrestrictive ventricular septal defect (VSD)...
Eligibility Criteria
Inclusion
- Undergoing cardiopulmonary bypass surgery with 1 of the following 5 procedures:
- AVSD repair
- VSD repair
- Bidirectional Glenn
- Modified Fontan
- Arterial switch
Exclusion
- Pulmonary artery or vein abnormalities not being addressed surgically
- Preoperative requirement for mechanical ventilation or intravenous inotrope support
- Any condition that might interfere with study objectives, as determined by the investigator
- Pregnant
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00335244
Start Date
May 1 2006
End Date
December 1 2009
Last Update
February 2 2015
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232