L-Citrulline in Surgery for Congenital Heart Defects - Clinical Trial

What is the Purpose of this Study?


We are doing this study to see if L-citrulline (the study drug) lessens the amount of time spent on mechanical ventilation (an automatic breathing machine) and decreases the amount of other medicines needed after surgery for congenital heart repair.

What is the Condition Being Studied?

Congenital Heart Problems

Who Can Participate in the Study?

Key Eligibility

Children younger than 18 who are scheduled to have cardiopulmonary bypass done at Duke to repair one of the following congenital defects:
- Large unrestrictive ventricular septal defect; OR
- Ostium primum/secundum atrial septal defect; OR
- Partial or complete atrioventricular septal defect

For more information about who can join this study, contact the study team at susan.hajmohammad@duke.edu.

Age Group

What is Involved?


If you agree to have your child join this study, they will:
- Get a random assignment (like a coin flip) to receive the study drug or placebo (an inactive substance)
- Receive 4 doses of the study drug or placebo
- Have blood draws
- Have a phone call with the study team after they go home from the hospital

Study Details

Full Title
A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
Principal Investigator
Protocol Number
IRB: PRO00112040
NCT: NCT05253209
Phase III
Enrollment Status
Open for Enrollment