Status:
COMPLETED
Management of Pleural Space Infections
Lead Sponsor:
Swedish Medical Center
Conditions:
Empyema, Pleural
Parapneumonic Effusion
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (...
Detailed Description
Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03873766
Start Date
April 1 2019
End Date
March 11 2022
Last Update
November 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Swedish Cancer Institute
Seattle, Washington, United States, 98104