Management of Pleural Space Infections
Empyema, Pleural, Parapneumonic Effusion
About this trial
This is an interventional treatment trial for Empyema, Pleural
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Clinical presentation compatible with pleural infection (fever or leukocytosis, elevated procalcitonin, elevated C-reactive protein (CRP))
Pleural fluid requiring drainage that is either:
- Macroscopically purulent or
- Positive on culture for bacterial infection or
- Positive for bacteria on gram stain or
- Lactate dehydrogenase (LDH) > 1000 IU/L or
- Glucose <40 mg/dL
Exclusion Criteria:
- Age <18 years
- Unable to give consent (No surrogate consent of legally authorized representatives allowed for this study)
- Not proficient in English
- History of prior ipsilateral empyema
- Has known sensitivity to DNase or alteplase
- History of intracranial hemorrhage or acute intracranial hemorrhage
- History of stroke, hemorrhage, or trauma within the last 3 months
- Has had prior surgery on the side of the pleural infection
- Patients who are pregnant or lactating
- Expected survival less than 6 months from a different pathology to this pleural infection based on clinical judgment
- Has a tunneled pleural catheter in place
- Patients on anticoagulation that cannot be interrupted for surgical intervention
- Patients with known or suspected malignant pleural effusion
- Patients with renal failure (Creatinine clearance <30)
- Prior history of or concern for chylothorax or pseudochylothorax
- Vulnerable populations: prisoners
Sites / Locations
- Swedish Cancer Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Intrapleural fibrinolytic therapy (IPFT)
Surgery
Procedure/Surgery: Pleural Sampling Procedure/Surgery: Pleural fluid drainage Protocol Image #1: After chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. Other: Surgical Consultation Intrapleural Medications (IPFT): The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion, a chest X-ray PA/lateral will be obtained Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
Procedure/Surgery: Pleural Sampling Procedure/Surgery: Pleural fluid drainage: Chest tube placement Protocol Image #1: Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. Other: Surgical Consultation Surgery: The surgical arm will have either open surgery or a VATS approach at the discretion of the surgeon Protocol Image #2: Chest X-ray PA/Lateral: The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained Quality of Life: Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires