Pleural Infection, Pleural Diseases
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERMedical Thoracoscopy
Medical thoracoscopy will be performed as per standard protocols.
OTHERFibrinolytic Group
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
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects \>18 years old with: * Evidence of empyema or complex parapneumonic effusion
Exclusion criteria
* Age \<18 years * Pregnancy * Inability to give informed written consent * Previous thoracic surgery or thrombolytic therapy for pleural infection * Medical thoracoscopy cannot be performed within 48 hours * Hemodynamic instability or severe hypoxemia * Non corrected coagulopathy * Homogeneously echogenic effusion on pleural ultrasonography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay after intervention | 12 week follow up period | Number of days hospitalized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total length of hospital stay | 12 week follow up period | Total days spent in the hospital |
| Failure rate of assigned treatment necessitating intervention | 12 week follow up period | 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 |
| Adverse events | 12 week follow up period | Any adverse event (pain or bleeding) |
| Number of days with chest drainage | 12 week follow up period | Number of days with chest drainage |
| 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 | 12 week follow up period | Pleural fluid volume measured with CT scan |
| Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively | at randomization and at 6 and12 week follow up visit | Inflammatory biomarker measure |
| Total costs of each treatment modality | 6 and 12 week follow up period | Total cost of each of treatment modality |
| In hospital and 30-day mortality | 30 days | Death of a patient while being hospitalized or up to 30 days after |
Countries
United States
Outcome results
None listed