Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

Denver Health and Hospital Authority

Status: Completed

Conditions: Coagulopathy; Empyema, Pleural; Parapneumonic Effusion

Treatments: Procedure: VATS Decortication; Drug: Fibrinolytic Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03583931

17-0857

Details and patient eligibility

About

This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.

Full description

The treatment of parapneumonic infections (infection in the pleural space) at the Denver Health Medical Center is not standardized, and timing for advanced interventions such as fibrinolytic therapy or surgical decortication remain unclear. The definitive treatment strategy in these patients may be sub-optimal, and lead to prolonged hospitalization and morbidity. This is concerning as the mortality rate of community acquired pneumonia triples in the presence of a parapneumonic process (5-15%) and can reach over 25% if it becomes bilateral(1). Prompt recognition of pleural space infections is essential for reducing morbidity and mortality. This is attributable to the progression of the disease from a simple fluid collection amenable to pleural space drainage, to necrotizing empyema requiring thoracotomy decortication and open drainage. The keys to management of parapneumonic effusions are early diagnosis, appropriate therapeutic intervention, and recognition of failure of conservative management. The investigators propose that a standardized pathway for identifying and treating parapneumonic effusions will be an important quality improvement. A key gap in the literature remains if patients with parapneumonic infections that cannot be drained with a chest tube should undergo a trial in intrapleural fibrinolytic therapy, or if they should go directly to video assisted thoracic surgery (VATS) for decortication of all infectious material.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old and older
• Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service
• Pleural fluid pH <7.3
• SICU placed chest tube
• Subsequent transfer to SICU

Exclusion criteria

• Existing malignancy
• Malignant cells from initial pleural fluid sample
• End stage liver disease (Child's B or greater)
• Coagulopathy
• Unable to tolerate surgical procedure
• Frank purulent drainage (needs OR regardless)
• Recent surgery of abdomen or thorax precluding the use of tPA
• Baseline neurologic impairment requiring a proxy for consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Operative VATS decortication

Active Comparator group

Description:

Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema

Treatment:

Procedure: VATS Decortication

Non-operative Fibrinolytic Therapy

Active Comparator group

Description:

Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.

Treatment:

Drug: Fibrinolytic Therapy