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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative VATS decortication | Active Comparator | Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema |
|
| Non-operative Fibrinolytic Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VATS Decortication | Procedure | Surgical procedure to unroof all located collections of the pleural space through a chest wall incision |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredric Pieracci, MD, MPH | Denver Health and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38710463 | Derived | 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. |
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Prospective randomized clinical trial of hospitalized patients identified to have complicated parapneumonic effusions with radiographic imaging. Denver Health and Hospital Authority.
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| ID | Title | Description |
|---|---|---|
| FG000 | Operative VATS Decortication | Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
10 subjects were enrolled. Five were randomized to the FT group and 5 to early VATS decortication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Operative VATS Decortication | Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision |
| BG001 | Non-operative Fibrinolytic Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay | How long the patient remains admitted in the hospital during their index hospitalization | Posted | Mean | Standard Deviation | days | 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. |
|
Through study completion, average of 1 year, which was the length of time participants were followed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operative VATS Decortication | Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | No pneumothorax related to study procedure, was due to the rupture of an abscess secondary to aspiration, causing a bronchopleural fistula |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| additional CT | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Subjects needed additional imaging |
Potential limitations to this study include a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Fredric Pieracci | Denver Health and Hospital Authority | 303-602-1863 | Fredric.Pieracci@dhha.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2019 | Jul 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016724 | Empyema, Pleural |
| D020141 | Hemostatic Disorders |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D004653 | Empyema |
| D013492 | Suppuration |
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| ID | Term |
|---|---|
| D015912 | Thrombolytic Therapy |
| D003851 | Deoxyribonucleases |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 |
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Prospective Randomized Clinical Trial
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| 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. |
|
|
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. |
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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | ICU Free Days | Admission days during index hospitalization that are of a lower acuity of care than intensive care | All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm. | Posted | Mean | Standard Deviation | Days | From admission to discharge, or for 28 days, whichever comes first. |
|
|
|
|
| Secondary | Chest Tube Days | Days with chest tube in place after intervention | All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm. | Posted | Mean | Standard Deviation | Days | 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 | The data were not collected | Posted | 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. | The pain score was provided at the discharge date or at 28 days of admission (whichever came first). | Posted | Mean | Standard Deviation | score on a scale | 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 | Incomplete analysis documented in records on this measure. | Posted | Mean | Standard Deviation | mL | 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 | No participants were analyzed on this measure in the final analysis, because the data were not collected. | Posted | 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 | All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm. | Posted | Mean | Standard Deviation | Days | 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) | All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm. | Posted | Mean | Standard Deviation | Days | From admission to discharge, or for 28 days, whichever comes first. |
|
|
|
|
| Secondary | Days of Antibiotics | The number of days antibiotics are required after intervention | All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm. | Posted | Mean | Standard Deviation | Days | 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 | All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm. | Posted | Mean | Standard Deviation | Days | From admission to discharge, or for 28 days, whichever comes first. |
|
|
|
|
| Secondary | Changed in Coagulopathic Status | Changes in laboratory TEG values after intervention | No participants were analyzed on this measure in the final analysis, because the data were not collected. | Posted | From admission to discharge, or for 28 days, whichever comes first. |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | 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. 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. | 1 | 5 | 2 | 5 | 1 | 5 |
|
| altered mental state | General disorders | Systematic Assessment | Not related to study; documented ICU delirium due to hospitalization for underlying disease, causing waxing and waning of consciousness. |
|
| unplanned readmission | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to study; patient readmitted for syncope, found to have non-occlusive pulmonary thrombus after being discharged from index hospitalization. |
|
|
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| D010995 |
| Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008171 | Lung Diseases |
| Enzymes |
| D045762 | Enzymes and Coenzymes |