Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery

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

Summary

This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• Undergoing cardiopulmonary bypass via one of the following surgical procedures:

1. AVSD repair

2. VSD repair

3. Bidirectional Glenn

4. Modified Fontan

5. Arterial Switch

• Parents willing and able to sign consent

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