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.
Adults (≥18 years old) capable of fully understanding the study;
Complicated pleural infection (macroscopically purulent fluid, positive for bacteria on Gram's staining, positive on culture for bacterial infection, loculated effusion, pH <7.2, great abundance) leading to thoracic drainage;
Initial ultrasound evaluation to estimate pleural fluid abundance and detect fibrinous septation;
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Tuberculous pleural effusions;
Previous treatment with intrapleural fibrinolytic agents (urokinase, streptokinase, alteplase, or DNase) or intrapleural saline lavage;
Previous thoracic surgery for pleural infection;
Contraindications to auxiliary treatments, to fibrinolysis or surgery as well as to procedures such as drainage and lavage;
Parallel
intrapleural irrigation
Drug500 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.
Standard care
Procedure/SurgeryStandard 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.
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.
Volume of pleural fluid drained from randomization
Volume of pleural fluid drained from randomization to day 3
Incidence of adverse events
Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction
Intra-hospital mortality
Intra-hospital mortality
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire, Amiens
Lead sponsor
University Hospital, Toulouse
Collaborator
Central Hospital Saint Quentin
Collaborator
CRC CHI Creteil France
Collaborator
University Hospital, Tours
Collaborator
Centre Hospitalier Universitaire de Nīmes
Collaborator
University Hospital, Brest
Collaborator
CH Morlaix
Collaborator
University Hospital, Caen
Collaborator
University Hospital, Rouen
Collaborator
University Hospital, Angers
Collaborator
Hospices Civils de Lyon
Collaborator
CH Pontoise
Collaborator
CH Avignon
Collaborator
Centre Hospitalier VALENCIENNES
Collaborator
CH Le Havre
Collaborator
Tenon Hospital, Paris
Collaborator
University Hospital, Bordeaux
Collaborator
Centre Hospitalier Argenteuil
Collaborator
University Hospital, Strasbourg, France
Collaborator
Nantes University Hospital
Collaborator
CH Haguenau
Collaborator
CHU de Reims
Collaborator
Centre Hospitalier Alpes Leman
Collaborator
Central Hospital, Nancy, France
Collaborator
