Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

NCT ID: NCT03583931

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2020-02-02

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.

Conditions

Parapneumonic Effusion; Empyema, Pleural; Coagulopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Operative VATS decortication

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

Group Type: ACTIVE_COMPARATOR

VATS Decortication

Intervention Type: PROCEDURE

Surgical procedure to unroof all located collections of the pleural space through a chest wall incision

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.

Group Type: ACTIVE_COMPARATOR

Fibrinolytic Therapy

Intervention Type: DRUG

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.

Interventions

VATS Decortication

Surgical procedure to unroof all located collections of the pleural space through a chest wall incision

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

DNAse / tPA combination therapy.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredric Pieracci, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital

Locations

Denver Health

Denver, Colorado, United States

Countries

United States

References

Barrett CD, Moore PK, Moore EE, Moore HB, Chandler JG, Siddiqui H, Maginot ER, Sauaia A, Perez-Calatayud AA, Buesing K, Wang J, Davila-Chapa C, Hershberger D, Douglas I, Pieracci FM, Yaffe MB. Neutrophil-Mediated Inflammatory Plasminogen Degradation, Rather Than High Plasminogen-Activator Inhibitor-1, May Underly Failures and Inefficiencies of Intrapleural Fibrinolysis. Chest. 2025 Jan;167(1):67-75. doi: 10.1016/j.chest.2024.04.005. Epub 2024 May 6.

Reference Type: DERIVED

PMID: 38710463 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-0857

Identifier Type: -

Identifier Source: org_study_id