Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

Coagulopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583931
• Other study ID #: 17-0857
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: February 2, 2020

Study information

• Verified date: November 2021
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coagulopathy
• Empyema
• Empyema, Pleural
• Parapneumonic Effusion

Intervention

Procedure:
• VATS Decortication
Surgical procedure to unroof all located collections of the pleural space through a chest wall incision

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.

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Chest Tube Days	Days with chest tube in place after intervention	From admission to discharge, or for 28 days, whichever comes first.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Days of Antibiotics	The number of days antibiotics are required after intervention	From admission to discharge, or for 28 days, whichever comes first.
Secondary	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.
Secondary	Changed in Coagulopathic Status	Changes in laboratory TEG values after intervention	From admission to discharge, or for 28 days, whichever comes first.