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NCT Number: NCT03583931

Treatment of Complicated Parapneumonic Effusion With 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VATS Decortication

Procedure

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

Fibrinolytic Therapy

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.

Other names: DNAse / tPA combination therapy.

Primary outcomes

  1. Hospital Length of Stay

    Time frame: 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 outcomes

  1. ICU Free Days

    Time frame: 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

  2. Chest Tube Days

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    Days with chest tube in place after intervention

  3. Cost of Admission and Treatment

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    Cost of care for the patient after their intervention

  4. Pain Score

    Time frame: 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.

  5. Chest Tube Drainage

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    The amount and character of the drainage from the chest tube after intervention

  6. Incentive Spirometry

    Time frame: 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

  7. Supplemental Oxygen Days

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    The amount of time the patient needs to warn off any supplemental oxygen

  8. Fever Days

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    The amount of days it takes to resolve fever (temp >100.4)

  9. Days of Antibiotics

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    The number of days antibiotics are required after intervention

  10. Elevated White Blood Count Days

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    The amount of days it takes to resolve a leukocytosis

  11. Changed in Coagulopathic Status

    Time frame: From admission to discharge, or for 28 days, whichever comes first.

    Changes in laboratory TEG values after intervention

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2018
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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