A Double-blind, Prospective, Randomized Trial of Propranolol for the Treatment of Postoperative Chylothorax After Open Cardiac Surgery
June Wu
Summary
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.
Description
This clinical trial will prospectively enroll eligible patients and randomize them to placebo or propranolol (1:1). This study will aim to enroll 50 patients, randomized to 25 placebo and 25 propranolol treatment. After patients have been consented, registered, and screened, they will be entered into the study. Participants will be randomized to placebo or propranolol in a 1:1 ratio. Randomization will be double-blinded, and each enrolled participant will be given a number and receive coded medication from the research pharmacy. Patients may undergo a screening MR lymphangiogram (MRL) prior to…
Eligibility
- Age range
- 0–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ≥7 days and ≤18 years old at time of original cardiac surgery * Congenital structural cardiac anomaly necessitating surgical correction. Examples include but are not limited to: ASD, VSD, single ventricles, HLHS, Tetralogy of Fallot, transposition of great vessels, AV canal, heart transplant * developed high output postoperative chylothorax (≥10mL/kg/day), or * persistent chylous drainage at any volume for ≥7 days after open heart surgery for a congenital cardiac defect * ≥70% lymphocytes, or * pleural triglyeride (TG) ≥ half of serum TG, or chylomicron positive * for…
Interventions
- DrugPropranolol Hydrochloride
Propranolol will be administered as tablets. Participants who are too young to swallow pills will be given propranolol solution.
- DrugPlacebo
Placebo suspension will only have Ora-Blend Medication Flavoring and Suspension Vehicle
Location
- Columbia University Irving Medical Center/NewYork-PresbyterianNew York, New York