Clinical trial NCT03583931: Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
Official title: Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parapneumonic Effusion
Empyema, Pleural
Coagulopathy
Keywords: VATS Decortication
Surgical Pleural Decortication
Fibrinolytic Therapy
Pneumonia
Thoracostomy
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: From patient's admission to hospital to their discharge, (excluding extended stay due to social work reasons) up to 28 days or discharge, which ever comes first.
Secondary outcomes:
measure: ICU Free Days
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Chest Tube Days
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Cost of Admission and Treatment
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Pain Score
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Chest Tube Drainage
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Incentive Spirometry
timeFrame: Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
measure: Supplemental Oxygen Days
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Fever Days
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Days of Antibiotics
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Elevated White Blood Count Days
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
measure: Changed in Coagulopathic Status
timeFrame: From admission to discharge, or for 28 days, whichever comes first.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Denver Health and Hospital
name: Fredric Pieracci, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: