Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asklepion Pharmaceuticals, LLC
• Collaborators: Vanderbilt University; Vanderbilt University Medical Center

Criteria

Inclusion Criteria:

• Undergoing cardiopulmonary bypass surgery with 1 of the following 5 procedures:

1. AVSD repair

2. VSD repair

3. Bidirectional Glenn

4. Modified Fontan

5. Arterial switch

Exclusion Criteria:

• 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