Actively Recruiting
Propranolol Treatment for Postoperative Chylothorax
Led by June Wu · Updated on 2025-10-20
50
Participants Needed
1
Research Sites
277 weeks
Total Duration
On this page
Sponsors
J
June Wu
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Postoperative chylothorax is a serious complication after open heart surgery for pediatric patients with congenital heart disease (CHD). While it was thought to be mechanical injury to the thoracic duct, recent research demonstrated that there are intrinsically abnormal lung lymphatics in CHD patients, and after open heart surgery, the fluid shifts that occur overwhelms these abnormal lung lymphatics. As a result, postoperative chylothorax occurs. Propranolol has been found to be helpful in resolving postoperative chylothorax very quickly (9 days) in a subset of postoperative chylothorax patients (60%). However, it is not known why some patients respond and some do not. The investigators hypothesize that propranolol is safe to use in this patient population, and that certain clinical factors will predict propranolol response, but more importantly, some clinical factors can be optimize to allow more patients with postoperative chylothorax to respond to and benefit from propranolol. In order to improve the understanding of how propranolol works and to maximize benefit to patients, the investigators propose to perform a prospective, randomized, double-blind clinical trial to learn how to best use propranolol in patients with postoperative chylothorax.
CONDITIONS
Official Title
Propranolol Treatment for Postoperative Chylothorax
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 7 days and 18 years old at the time of original cardiac surgery
- Have a congenital structural heart defect requiring surgery, such as ASD, VSD, single ventricle, HLHS, Tetralogy of Fallot, transposition of great vessels, AV canal, or heart transplant
- Developed high-output postoperative chylothorax (10 mL/kg/day or more), or have persistent chylous drainage at any volume for 7 days or longer after surgery
- Have 70% or more lymphocytes in pleural fluid, or pleural triglyceride level at least half of serum triglyceride, or positive chylomicrons
- For patients with lower than normal serum lymphocyte count, have at least 60% lymphocytes in pleural fluid
- Have measurable chylothorax output
- Accept any level of respiratory support (room air, oxygen, CPAP/BIPAP, ventilator)
- Accept any level of inpatient support (ICU, step-down unit, floor)
- Can be on or start treatment for postoperative chylothorax before or during the study
- Can continue or start new treatments for primary heart or other medical conditions during the trial
- Have adequate kidney function
- Not on dialysis
- No unstable low heart rate or second or third degree heart block
- No systolic low blood pressure not corrected by pressor support
- No history of asthma
- Parent or legal guardian must provide written informed consent and HIPAA authorization
- Must enroll in a related study collecting chylothorax fluid for cell and genetic analysis
You will not qualify if you...
- Pregnancy
- Kidney failure at enrollment
- Low blood pressure despite pressor support
- Unstable low heart rate without pacing ability
- History of asthma or chronic use of bronchodilators
- Uncontrolled low or high blood sugar as judged by investigators
- Failure to start propranolol after two attempts due to significant blood pressure or heart rate drop
- Experiencing severe adverse events (Grade 3 or higher)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center/NewYork-Presbyterian
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
June Wu, MD
CONTACT
S
Shannon Brackett, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here