Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intrapleural irrigation, Standard care.
- Who it may be relevant to
- Registry conditions: Therapy, Pleural Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial Comparing an Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.
Overview
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.
Interventions
- Drug 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. - Procedure 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.
Primary outcome measures
- Number of treatment failure [Time frame: at 30 days]
Secondary outcome measures (11)
- Volume of pleural fluid drained from randomization [Time frame: at day 3]
- Incidence of adverse events [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 [Time frame: at 30 days]
- Rate of additional intrapleural enzyme therapy [Time frame: at 30 days]
- Length of hospital stay [Time frame: at 90 days]
- Change in the area of pleural opacity [Time frame: at day 3]
- Presence of a restrictive ventilatory defect [Time frame: at day 90]
- Assessment of pain using a numeric pain scale [Time frame: at 90 days]
- valuation of the prognostic performance of the RAPID score [Time frame: at day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens Picardie — Amiens
Identifiers
NCT: NCT07666464 · PI2025_843_0088