Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
Completed · Phase 3 · Has a placebo group
Conditions studied: Heart Defects, Congenital, Hypertension, Pulmonary
In brief
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.
Key facts
- Study ID
- NCT00335244
- Run by
- Asklepion Pharmaceuticals, LLC
- People needed
- 77
- Starts
- 2006-05-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2015-02-02
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing cardiopulmonary bypass surgery with 1 of the following 5 procedures:
- AVSD repair
- VSD repair
- Bidirectional Glenn
- Modified Fontan
- Arterial switch
You may not qualify if…
- Pulmonary artery or vein abnormalities not being addressed surgically
- Preoperative requirement for mechanical ventilation or intravenous inotrope support
- Any condition that might interfere with study objectives, as determined by the investigator
- Pregnant
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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