Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

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.

Study Overview

• Status: Completed
• Conditions: Coagulopathy; Empyema, Pleural; Parapneumonic Effusion
• Intervention / Treatment: Procedure: VATS Decortication; Drug: Fibrinolytic Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Operative VATS decortication; Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema	Procedure: VATS Decortication; Surgical procedure to unroof all located collections of the pleural space through a chest wall incision
Active Comparator: Non-operative 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.	Drug: Fibrinolytic Therapy; Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive.; Other Names: DNAse / tPA combination therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	How long the patient remains admitted in the hospital during their index hospitalization	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Free Days	Admission days during index hospitalization that are of a lower acuity of care than intensive care	From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Days	Days with chest tube in place after intervention	From admission to discharge, or for 28 days, whichever comes first.
Cost of Admission and Treatment	Cost of care for the patient after their intervention	From admission to discharge, or for 28 days, whichever comes first.
Pain Score	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.	From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Drainage	The amount and character of the drainage from the chest tube after intervention	From admission to discharge, or for 28 days, whichever comes first.
Incentive Spirometry	To what volume the patient can inspire using an incentive spirometer	Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
Supplemental Oxygen Days	The amount of time the patient needs to warn off any supplemental oxygen	From admission to discharge, or for 28 days, whichever comes first.
Fever Days	The amount of days it takes to resolve fever (temp >100.4)	From admission to discharge, or for 28 days, whichever comes first.
Days of Antibiotics	The number of days antibiotics are required after intervention	From admission to discharge, or for 28 days, whichever comes first.
Elevated White Blood Count Days	The amount of days it takes to resolve a leukocytosis	From admission to discharge, or for 28 days, whichever comes first.
Changed in Coagulopathic Status	Changes in laboratory TEG values after intervention	From admission to discharge, or for 28 days, whichever comes first.

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Investigators: Principal Investigator: Fredric Pieracci, MD, MPH, Denver Health and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): February 2, 2020

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pneumonia; VATS Decortication; Surgical Pleural Decortication; Fibrinolytic Therapy; Thoracostomy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Inflammation; Pleural Diseases; Suppuration; Empyema; Empyema, Pleural
• Other Study ID Numbers: 17-0857

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No