Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

Status:Enrolling by invitation
Conditions:Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Age Range:18 - Any
Start Date:July 26, 2018
End Date:April 1, 2024

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Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication

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.

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.

Inclusion Criteria:

- 18 years old and older

- Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary

- 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
We found this trial at
Denver, Colorado 80204
Denver, CO
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