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Report for Clinical Trial NCT00201214
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
This study will determine the pharmacokinetics and safety of intravenous citrulline given to
children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
Description: Phase I - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with dosage escalation study 50mg/kg, 100mg/kg, 150mg/kg IV at 6, 12, 24, 48 hours post operative. Phase II - 150mg/kg IV bolus after initiation of cardiopulmonary bypass with 9mg/kg/hr continuous IV starting 4 hours post bolus and infusing for 48 hours or discharge from PCCU.
Primary Outcomes Measure: Oxygen index (OI) data to assess increased PVT Time: Measured through the use of continuous mean arterial pressure monitoring
Measure: Qp:Qs ratios to assess increased PVT Time: Measured by blood gases collected 48 hours post-operative
Measure: Increased PVT as measured by a sustained mean pulmonary artery pressure greater than 20 mm Hg for at least 2 hours during the first 24 hours postoperatively Time: Measured through the use of continuous mean arterial pressure monitoring 48 hours post-operative
Single Group Assignment
There is one SNP
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 ---