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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
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.
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.
CHU Amiens Picardie
Amiens, Picardie, France
RECRUITINGNumber 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.
Time frame: at 30 days
Volume of pleural fluid drained from randomization
Volume of pleural fluid drained from randomization to day 3
Time frame: at day 3
Incidence of adverse events
Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction
Time frame: at 90 days
Intra-hospital mortality
Time frame: at 30 days
Intra-hospital mortality
Time frame: at 90 days
Rate of thoracic surgery
Rate of thoracic surgery
Time frame: at 30 days
Rate of additional intrapleural enzyme therapy
Rate of additional intrapleural enzyme therapy
Time frame: at 30 days
Length of hospital stay
Length of hospital stay
Time frame: 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;
Time frame: at day 3
Presence of a restrictive ventilatory defect
Presence of a restrictive ventilatory defect, defined as total lung capacity \< 80% of predicted values
Time frame: at day 90
Assessment of pain using a numeric pain scale
Assessment of pain using a numeric pain scale
Time frame: at 90 days
valuation of the prognostic performance of the RAPID score
valuation of the prognostic performance of the RAPID score
Time frame: at day 0
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