Phase 3Completed
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
A Phase III Single-Blind, Randomized, Placebo Controlled, Clinical Trial to Determine the Safety and Efficacy of Intravenous L-Citrulline Versus Placebo in Children Undergoing Cardiopulmonary Bypass
- Sponsor
- Asklepion Pharmaceuticals, LLC (Industry)
- Enrollment
- 77 enrolled
- Conditions
- Heart Defects, Congenital; Hypertension, Pulmonary
- Interventions
- L-citrulline; Placebo of intravenous L-citrulline
- Ages
- children
- Registry
- NCT00335244
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Duration of postoperative mechanical ventilation in hours compared between treatment groups.
History
Last registry update
Primary completion
Registered
Started