Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.
The objective of this study is to determine in a randomized placebo controlled phase IB
multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given
perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing
surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular
septal defect.