Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201214
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2005-09-16
Brief Title:
Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Phase III Clinical Trial to Determine the Pharmacokinetics and Safety Profile of Citrulline in Children Undergoing Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 III 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
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 III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL073317 | NIH | None | httpsreporternihgovquickSearchR01HL073317 |