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.
Who Can Participate?
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.
- 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 Range
0-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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
- 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
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Evenings
Compensation
No
Spanish Materials Available
Yes
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
Ziv
Beckerman
Protocol Number
PRO00112040
NCT ID
NCT05253209
Phase
III
Enrollment Status
OPEN TO ACCRUAL