SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00335244
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
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.
Name: L-citrulline
Description: 150mg bolus X 1 after initiation of cardiopulmonary bypass followed by continuous infusion of 9mg/kg/hr IV, starting 4 hours post bolus administration and ending at 48 hours continuous infusion or discharge from the PCCU
Type: Drug
Name: Placebo of intravenous L-citrulline
Description: Placebo of intravenous L-citrulline
Type: Drug
Primary Outcomes
Measure: Duration of postoperative mechanical ventilation in hours compared between treatment groups. Time: Measured in hours from the end of surgery until extubation
Secondary Outcomes
Measure: Incidence of increased PVT (defined as a sustained mean pulmonary artery pressure greater than 20 mm Hg for at least 2 hours, measured during the first 48 hours Time: Measured in hours from the end of surgery until extubation
Measure: Postoperative intravenous inotrope score Time: Measured at 48 hours
Measure: Length and volume of chest tube drainage Time: Measured in hours from the end of surgery until removal of chest tubes
Measure: Length of ICU stay Time: Measured in hours from the end of surgery to discharge from ICU
Measure: Length of hospitalization Time: Measured from the day of surgery until discharge from hospital
Measure: Survival Time: Measured at 30 days post surgical repair
Purpose: Prevention
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 T1405N
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. --- T1405N ---