Propranolol for postoperative chylothorax in children and adolescents
A Double-blind, Prospective, Randomized Trial of Propranolol for the Treatment of Postoperative Chylothorax After Open Cardiac Surgery
PHASE1; PHASE2 · Columbia University · NCT06833320
This study will try propranolol versus placebo to see if it quickly stops chylous chest drainage in children and teens after open-heart surgery for congenital heart defects.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 7 Days to 18 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06833320 on ClinicalTrials.gov |
What this trial studies
Eligible pediatric patients who develop postoperative chylothorax after corrective surgery for congenital heart disease will be randomized 1:1 to receive propranolol or matching placebo in a double-blind design. Study medication will be given for up to 9 days at the lowest effective dose not to exceed 2 mg/kg/day, after which treatment allocation will be unmasked. An optional MR lymphangiogram may be performed before treatment only in patients who are already sedated or can undergo MRI without additional sedation. Responders are defined as those receiving propranolol who achieve a ≥80% reduction in chylous drainage volume at 9 days and will be tapered off medication and removed from further study interventions.
Who should consider this trial
Good fit: Children and adolescents who developed measurable postoperative chylothorax after open-heart surgery for congenital heart disease, with chylous fluid confirmed by lymphocyte count, pleural triglyceride criteria, or chylomicrons, are eligible.
Not a fit: Patients without measurable chylous output, those with contraindications to beta-blockers, or those who require immediate surgical or interventional lymphatic repair are unlikely to benefit from this treatment approach.
Why it matters
Potential benefit: If successful, propranolol could rapidly reduce chylous drainage, shorten hospital stays, and reduce the need for invasive lymphatic interventions in children after heart surgery.
How similar studies have performed: Prior case series reported propranolol resolved postoperative chylothorax in about 60% of patients within a median of 9 days, but randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York
- Columbia University Irving Medical Center/NewYork-Presbyterian — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: June Wu, MD — Columbia University Irving Medical Center/ New York Presbyterian hospital
- Study coordinator: June Wu, MD
- Email: jw92@cumc.columbia.edu
- Phone: 212-342-3704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Chylothorax, Congenital Heart Disease, Open Heart Surgery, Chylothorax