Propranolol for Chylothorax
Trial Summary
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. Participants can continue their ongoing treatments and start new ones for their primary cardiac or other medical conditions during the trial.
What data supports the effectiveness of the drug propranolol for treating chylothorax?
Is propranolol generally safe for use in humans?
How does the drug propranolol differ from other treatments for chylothorax?
Propranolol is unique because it is a nonselective beta-blocker that has shown promise in treating chylothorax, a condition with no well-established medical therapies, by potentially improving lymphatic function and reducing pleural effusion. Unlike other treatments like octreotide, which can have serious side effects, propranolol has been used safely in both prenatal and postnatal settings, showing improvement in clinical signs without significant complications.12389
What is the purpose of this trial?
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.
Research Team
June Wu, MD
Principal Investigator
Columbia University Irving Medical Center/ New York Presbyterian hospital
Eligibility Criteria
This trial is for pediatric patients with congenital heart disease who have developed chylothorax after open heart surgery. The study aims to include those who may benefit from Propranolol treatment. Specific eligibility criteria are not provided, but typically would involve age and health status considerations.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive propranolol or placebo for 9 days after reaching the lowest effective goal dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including daily blood pressure, heart rate, and glucose level measurements
Open-label extension
Participants in the placebo group with <80% reduction in chylothorax drainage receive propranolol for 9 days in an open-label setting
Treatment Details
Interventions
- Propranolol
Find a Clinic Near You
Who Is Running the Clinical Trial?
June Wu
Lead Sponsor
United States Department of Defense
Collaborator