The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion (CPPE) in adults.
Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies. Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic Therapy group. Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting Primary Outcome: Duration of hospital stay after intervention Secondary Outcome: Failure rate of assigned treatment and adverse events Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Medical thoracoscopy will be performed as per standard protocols.
Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Duration of hospital stay after intervention
Number of days hospitalized
Time frame: 12 week follow up period
Number of days with chest drainage
Number of days with chest drainage
Time frame: 12 week follow up period
Total length of hospital stay
Total days spent in the hospital
Time frame: 12 week follow up period
Failure rate of assigned treatment necessitating intervention
defined as any of the following: 1. Surgical intervention (VATS, open thoracotomy) in the medical thoracoscopy or fibrinolytic therapy arm 2. Need of additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to clinical non-responsiveness 3. Need of additional chest tube in the fibrinolytic therapy arm due to clinical non-responsiveness
Time frame: 12 week follow up period
Adverse events
Any adverse event (pain or bleeding)
Time frame: 12 week follow up period
In hospital and 30-day mortality
Death of a patient while being hospitalized or up to 30 days after
Time frame: 30 days
Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software
Pleural fluid volume measured with CT scan
Time frame: 12 week follow up period
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Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively
Inflammatory biomarker measure
Time frame: at randomization and at 6 and12 week follow up visit
Total costs of each treatment modality
Total cost of each of treatment modality
Time frame: 6 and 12 week follow up period