Propranolol Treatment for Postoperative Chylothorax

Launched by JUNE WU · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called propranolol to treat a condition known as postoperative chylothorax in children who have undergone open heart surgery for congenital heart disease. Postoperative chylothorax is when excess lymphatic fluid builds up in the chest after surgery, which can be a serious complication. The researchers want to find out if propranolol is safe and effective for helping more patients recover from this condition. They believe that certain factors about a patient's health might help predict who will respond well to the treatment.

To be eligible for the trial, participants must be between 7 days and 18 years old and have had heart surgery for congenital heart defects, such as holes in the heart or other structural issues. They should also have developed a significant amount of chylothorax after surgery. If you or your child are interested in participating, you will need to provide consent, and a parent or guardian will need to sign forms to allow participation in this study. Throughout the trial, participants will be monitored closely, and they can continue other treatments for their heart conditions. This study aims to improve how this medication can be used to help children with postoperative chylothorax recover more quickly and effectively.

Gender

ALL

Eligibility criteria

• 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)