Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06833320

PHASE1/PHASE2

Propranolol Treatment for Postoperative Chylothorax

Sponsor: June Wu

View on ClinicalTrials.gov

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.

Official title: A Double-blind, Prospective, Randomized Trial of Propranolol for the Treatment of Postoperative Chylothorax After Open Cardiac Surgery

Key Details

Gender

All

Age Range

7 Days - 18 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-09

Completion Date

2031-01-01

Last Updated

2025-10-20

Healthy Volunteers

Conditions

Postoperative Chylothorax Congenital Heart Disease Open Heart Surgery Chylothorax

Interventions

DRUG

Propranolol Hydrochloride

Propranolol will be administered as tablets. Participants who are too young to swallow pills will be given propranolol solution.

DRUG

Placebo

Placebo suspension will only have Ora-Blend Medication Flavoring and Suspension Vehicle

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 patients with lower than normal serum lymphocyte count (agedependent), ≥60% lymphocytes in pleural fluids * Must have measurable output (chylothorax output in mL) * Any level of respiratory support (room air, supplemental oxygen, CPAP/BIPAP, ventilatory support) * Any level of inpatient support (ICUs, step-down units, floor) * Study participants can be on concomitant treatment for postoperative chylothorax started prior to study initiation * Study participants can continue on on-going treatment for their primary cardiac other medical conditions * Study participants can initiate new treatments for their primary cardiac or other medical conditions during trial period * Adequate renal function * Not on dialysis * No hemodynamically unstable bradycardia * No systolic hypotension not corrected by pressor support * Not in 2nd or 3rd degree heart block * No history of asthma * A parent or a legal guardian must sign a written informed consent and HIPAA Form * Patients will be required to also be enrolled in a related study (AAAQ6902) which collects chylothorax fluid for cell isolation and genetic analysis Exclusion Criteria: * Pregnancy * Renal failure at time of enrollment * Hypotension despite pressor support * Unstable bradycardia without capacity for pacing * History of asthma or chronic bronchodilator therapy * Uncontrolled hypoglycemia or hyperglycemia as per investigators' judgment * Study participant will be removed from study if they failed 2 consecutive attempts to initiate propranolol (\>10% drop in BP/HR from age-adjusted normative range) * Study participant experiences ≥ Grade 3 AE (SAE)

Locations (1)

Columbia University Irving Medical Center/NewYork-Presbyterian

New York, New York, United States