RECRUITING

Propranolol Treatment for Postoperative Chylothorax

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Conditions

Postoperative ChylothoraxCongenital Heart DiseaseOpen Heart SurgeryChylothorax

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-09-09
Study Completion:2031-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06833320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Days to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥7 days and ≤18 years old at time of original cardiac surgery
  2. * 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
  3. * developed high output postoperative chylothorax (≥10mL/kg/day), or
  4. * persistent chylous drainage at any volume for ≥7 days after open heart surgery for a congenital cardiac defect
  5. * ≥70% lymphocytes, or
  6. * pleural triglyeride (TG) ≥ half of serum TG, or chylomicron positive
  7. * for patients with lower than normal serum lymphocyte count (agedependent), ≥60% lymphocytes in pleural fluids
  8. * Must have measurable output (chylothorax output in mL)
  9. * Any level of respiratory support (room air, supplemental oxygen, CPAP/BIPAP, ventilatory support)
  10. * Any level of inpatient support (ICUs, step-down units, floor)
  11. * Study participants can be on concomitant treatment for postoperative chylothorax started prior to study initiation
  12. * Study participants can continue on on-going treatment for their primary cardiac other medical conditions
  13. * Study participants can initiate new treatments for their primary cardiac or other medical conditions during trial period
  14. * Adequate renal function
  15. * Not on dialysis
  16. * No hemodynamically unstable bradycardia
  17. * No systolic hypotension not corrected by pressor support
  18. * Not in 2nd or 3rd degree heart block
  19. * No history of asthma
  20. * A parent or a legal guardian must sign a written informed consent and HIPAA Form
  21. * Patients will be required to also be enrolled in a related study (AAAQ6902) which collects chylothorax fluid for cell isolation and genetic analysis
  1. * Pregnancy
  2. * Renal failure at time of enrollment
  3. * Hypotension despite pressor support
  4. * Unstable bradycardia without capacity for pacing
  5. * History of asthma or chronic bronchodilator therapy
  6. * Uncontrolled hypoglycemia or hyperglycemia as per investigators' judgment
  7. * 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)
  8. * Study participant experiences ≥ Grade 3 AE (SAE)

Contacts and Locations

Study Contact

June Wu, MD
CONTACT
212-342-3704
jw92@cumc.columbia.edu
Shannon Brackett, NP
CONTACT
212-342-3704
snb2163@cumc.columbia.edu

Principal Investigator

June Wu, MD
PRINCIPAL_INVESTIGATOR
Columbia University Irving Medical Center/ New York Presbyterian hospital

Study Locations (Sites)

MS CHONY inpatient units, including regular floor units, stepdown units, and ICU
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: June Wu

  • June Wu, MD, PRINCIPAL_INVESTIGATOR, Columbia University Irving Medical Center/ New York Presbyterian hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-09
Study Completion Date2031-01-01

Study Record Updates

Study Start Date2025-09-09
Study Completion Date2031-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Postoperative Chylothorax
  • Congenital Heart Disease
  • Open Heart Surgery
  • Chylothorax