Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335244
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2006-06-07
Brief Title:
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
Sponsor:
Asklepion Pharmaceuticals LLC
Organization:
Asklepion Pharmaceuticals LLC
Study Overview
Official Title:
A Phase III Single-Blind Randomized Placebo Controlled Clinical Trial to Determine the Safety and Efficacy of Intravenous L-Citrulline Versus Placebo in Children Undergoing Cardiopulmonary Bypass
Status:
COMPLETED
Status Verified Date:
2015-01
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 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 to either L-citrulline or a placebo a substance that has no medicine in it
Citrulline is a protein building block in the body that can convert into another substance nitric oxide NO which controls blood pressure in the lungs Increased blood pressure in the lungs can be an important surgical problem it may also lead to problems following surgery such as severe high blood pressure in the lungs pulmonary hypertension increased time spent on a breathing machine and a longer stay in the intensive care unit ICU The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation
Citrulline is a protein building block in the body that can convert into another substance nitric oxide NO which controls blood pressure in the lungs Increased blood pressure in the lungs can be an important surgical problem it may also lead to problems following surgery such as severe high blood pressure in the lungs pulmonary hypertension increased time spent on a breathing machine and a longer stay in the intensive care unit ICU The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation
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 repair 2 atrioventricular septal AVSD repair 3 arterial switch procedure for transposition of the great arteries TGA 4 bidirectional Glenn shunt procedure and 5 Fontan procedure for single ventricle lesions PVT is partially controlled by 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 six previous surgical procedures It was found that urea cycle function and plasma arginine levels were significantly decreased in all participants Furthermore participants with increased PVT had significantly lower arginine levels compared to participants 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
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 |
|---|---|---|---|
| R01HL073317-01 | NIH | None | None |
| IRB 060197 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01HL073317-01 |