intrapleural irrigation: 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: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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;
* Social security affiliation
* Written informed consent
* Highly effective contraceptive methods for women of childbearing age include: Combined hormonal contraception (estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; hormone- releasing intrauterine system; bilateral occlusion of the Fallopian tubes; vasectomized partner; sexual abstinence
Exclusion Criteria:
* 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;
* Pregnancy or lactation;
* Expected survival of less than 3 months;
* Thoracic drainage since more than 24h;
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision);
* Inability to give informed written consent;
* Participation in another clinical trial;
* Patient being a relative of the investigator or any member of the team directly involved in the study, including assistant physicians, pharmacists, nurses, and coordinators
Primary outcome measure(s)
Number of treatment failure — at 30 days 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.
Trial sites (1)
Facility
City
Region
Status
CHU Amiens Picardie
Amiens
Picardie
Recruiting
More Centre Hospitalier Universitaire, Amiens trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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