Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

Not Applicable

Completed

Conditions: Coagulopathy
Empyema, Pleural
Parapneumonic Effusion

Interventions: Procedure: VATS Decortication
Drug: Fibrinolytic Therapy

Registration Number: NCT03583931

Lead Sponsor: Denver Health and Hospital Authority

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative VATS decortication	VATS Decortication	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema
Non-operative Fibrinolytic Therapy	Fibrinolytic Therapy	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.

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	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.	How long the patient remains admitted in the hospital during their index hospitalization

Secondary Outcome Measures

Name	Time	Method
Supplemental Oxygen Days	From admission to discharge, or for 28 days, whichever comes first.	The amount of time the patient needs to warn off any supplemental oxygen
Fever Days	From admission to discharge, or for 28 days, whichever comes first.	The amount of days it takes to resolve fever (temp \>100.4)
Days of Antibiotics	From admission to discharge, or for 28 days, whichever comes first.	The number of days antibiotics are required after intervention
Changed in Coagulopathic Status	From admission to discharge, or for 28 days, whichever comes first.	Changes in laboratory TEG values after intervention
ICU Free Days	From admission to discharge, or for 28 days, whichever comes first.	Admission days during index hospitalization that are of a lower acuity of care than intensive care
Chest Tube Days	From admission to discharge, or for 28 days, whichever comes first.	Days with chest tube in place after intervention
Incentive Spirometry	Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.	To what volume the patient can inspire using an incentive spirometer
Pain Score	From admission to discharge, or for 28 days, whichever comes first.	What the patient's level of pain is from 0 to 10; zero being no pain, 10 being the worst pain imaginable. score is categorical 0,1,2,3,4,5,6,7,8,9 or 10.
Elevated White Blood Count Days	From admission to discharge, or for 28 days, whichever comes first.	The amount of days it takes to resolve a leukocytosis
Cost of Admission and Treatment	From admission to discharge, or for 28 days, whichever comes first.	Cost of care for the patient after their intervention
Chest Tube Drainage	From admission to discharge, or for 28 days, whichever comes first.	The amount and character of the drainage from the chest tube after intervention