Management of Pleural Space Infections

• Status: Recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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 (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition.

This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Swedish Medical Center

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