Sponsor study identifier
Secondary identifiers
NIH
interventional
26
1 country
1
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2006
Actual (reported)Study Completion
December 2009
Actual (reported)This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 16, 2005
Actual (reported)September 20, 2005
Actual (reported)January 2006
Actual (reported)December 2009
Actual (reported)Oxygen index (OI) data to assess increased PVT
Measured through the use of continuous mean arterial pressure monitoring
Qp:Qs ratios to assess increased PVT
Measured by blood gases collected 48 hours post-operative
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
Measured through the use of continuous mean arterial pressure monitoring 48 hours post-operative
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vanderbilt University
Nashville, Tennessee, 37212, United States
Barr FE, Tirona RG, Taylor MB, Rice G, Arnold J, Cunningham G, Smith HA, Campbell A, Canter JA, Christian KG, Drinkwater DC, Scholl F, Kavanaugh-McHugh A, Summar ML. Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension. J Thorac Cardiovasc Surg. 2007 Aug;134(2):319-26. doi: 10.1016/j.jtcvs.2007.02.043.
Frederick E. Barr, MD, MSCI
Vanderbilt University
26 participants (actual enrollment reported by the registry).
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Interactive Technologies to Increase Exercise Behavior
Contact the study team to confirm eligibility.
Primary Completion
January 2006
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
September 12, 2013
Record last verified: 2013-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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