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| Name | Class |
|---|---|
| University Hospital, Toulouse | OTHER |
| Central Hospital Saint Quentin | OTHER_GOV |
| CRC CHI Creteil France | OTHER_GOV |
| University Hospital, Tours |
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Intrapleural enzyme therapy (IET) is regarded by recent guidelines as a "rescue" therapy for managing complicated pleural infections; however, it is associated with significant side effects, including pleural bleeding, pain, and fever. Pleural irrigation with saline may serve as an alternative, yet evidence supporting its effectiveness is limited to a single small- scale, single-center randomized trial. The objective of the study is to compare the risk of treatment failure at 30 days (defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy) between an early pleural irrigation strategy and standard care for complicated pleural infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intrapleural irrigation | Experimental | Experimental group: 500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur twices daily for a total of 6 irrigations. |
|
| standard care | Active Comparator | Control group: Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered twice daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrapleural irrigation | Drug | 500 mL bags of 0.9% sodium chloride will be administered into the thoracic cavity via the chest tube using a three way tap and gravity (no infusion pump or pressure). The infusion is followed by free drainage with thoracic suction (up to -20 cmH2O). This process will occur two times daily for a total of 6 irrigations. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment failure | Treatment failure, defined as a composite outcome that includes death, the need for thoracic surgery, or additional intrapleural enzyme therapy. This criterion will be assessed at 30 days. | at 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of pleural fluid drained from randomization | Volume of pleural fluid drained from randomization to day 3 | at day 3 |
| Incidence of adverse events | Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damien BASILLE, Pr | Contact | 33+3 22 45 59 10 | basille.damien@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | Picardie | 80054 | France |
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| OTHER |
| Centre Hospitalier Universitaire de Nīmes | OTHER |
| University Hospital, Brest | OTHER |
| CH Morlaix | UNKNOWN |
| University Hospital, Caen | OTHER |
| University Hospital, Rouen | OTHER |
| University Hospital, Angers | OTHER_GOV |
| Hospices Civils de Lyon | OTHER |
| CH Pontoise | UNKNOWN |
| CH Avignon | UNKNOWN |
| Centre Hospitalier VALENCIENNES | OTHER |
| CH Le Havre | UNKNOWN |
| Tenon Hospital, Paris | OTHER |
| University Hospital, Bordeaux | OTHER |
| Centre Hospitalier Argenteuil | OTHER |
| University Hospital, Strasbourg, France | OTHER |
| Nantes University Hospital | OTHER |
| CH Haguenau | UNKNOWN |
| CHU de Reims | OTHER |
| Centre Hospitalier Alpes Leman | OTHER |
| Central Hospital, Nancy, France | OTHER |
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|
| Standard care | Procedure | Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered two times daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes. |
|
| at 90 days |
| Intra-hospital mortality | at 30 days |
| Intra-hospital mortality | at 90 days |
| Rate of thoracic surgery | Rate of thoracic surgery | at 30 days |
| Rate of additional intrapleural enzyme therapy | Rate of additional intrapleural enzyme therapy | at 30 days |
| Length of hospital stay | Length of hospital stay | at 90 days |
| Change in the area of pleural opacity | Change in the area of pleural opacity, measured as the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography from randomization to day 3; | at day 3 |
| Presence of a restrictive ventilatory defect | Presence of a restrictive ventilatory defect, defined as total lung capacity < 80% of predicted values | at day 90 |
| Assessment of pain using a numeric pain scale | Assessment of pain using a numeric pain scale | at 90 days |
| valuation of the prognostic performance of the RAPID score | valuation of the prognostic performance of the RAPID score | at day 0 |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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