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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00201214 |
This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Heart Diseases Heart Defects, Congenital |
Drug: Citrulline |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Phase I/II Clinical Trial to Determine the Pharmacokinetics and Safety Profile of Citrulline in Children Undergoing Cardiopulmonary Bypass |
Enrollment: | 26 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
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 defect (VSD) repair; 2) atrioventricular septal (AVSD) repair; 3) arterial switch procedure for transposition of the great arteries (TGA); 4) Norwood I procedure; 5) bidirectional Glenn shunt procedure; and 6) Fontan procedure for single ventricle lesions. PVT is partially controlled by nitric oxide (NO). Arginine, the precursor to NO, is a product of the urea cycle. Preliminary data have been presented regarding 169 infants and children who have undergone one of the six previous surgical procedures. It was found that urea cycle function and plasma arginine levels were significantly decreased in all patients. Furthermore, patients with increased PVT had significantly lower arginine levels compared to patients with normal PVT. Finally, a genetic single nucleotide polymorphism (SNP) in the rate limiting urea cycle enzyme (carbamyl phosphate synthetase I [CPSl T1405N]) appeared to affect postoperative plasma arginine levels and PVT. The hypothesis is that genetic polymorphisms in the rate limiting urea cycle enzyme CPSl, and other important enzymes in the urea cycle, influence the availability of NO precursors. It is further hypothesized that perioperative enhancement of urea cycle function with the key urea cycle intermediate (citrulline) will increase plasma arginine and NO metabolites, and prevent elevations in PVT.
DESIGN NARRATIVE:
This phase I/II study will determine the pharmacokinetics and safety of three doses of intravenous citrulline that will be given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Undergoing cardiopulmonary bypass via one of the following surgical procedures:
Exclusion Criteria:
Responsible Party: | Vanderbilt University Medical Center ( Frederick E. Barr, M.D. ) |
Study ID Numbers: | 281, R01 HL73317 |
Study First Received: | September 16, 2005 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00201214 History of Changes |
Health Authority: | United States: Federal Government |
Heart Diseases Cardiovascular Abnormalities Congenital Abnormalities Heart Defects, Congenital |
Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |