Status:
COMPLETED
Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
Detailed Description
BACKGROUND: Increased pulmonary vascular tone (PVT) can complicate the postoperative course of the following six surgical procedures for congenital heart defects: 1) unrestrictive ventricular septal ...
Eligibility Criteria
Inclusion
- Undergoing cardiopulmonary bypass via one of the following surgical procedures:
- AVSD repair
- VSD repair
- Bidirectional Glenn
- Modified Fontan
- Arterial Switch
- Parents willing and able to sign consent
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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00201214
Start Date
December 1 2003
End Date
December 1 2009
Last Update
September 12 2013
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37212