Comparison of Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.

Официальное название

Randomized Controlled Trial Comparing an Early Pleural Irrigation Strategy With Saline to the Standard of Care for the Management of Complicated Pleural Infections.

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура 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.

Первичные конечные точки

• Number of treatment failure [Срок оценки: at 30 days]

Вторичные конечные точки (11)

• Volume of pleural fluid drained from randomization [Срок оценки: at day 3]
• Incidence of adverse events [Срок оценки: at 90 days]
• Intra-hospital mortality [Срок оценки: at 30 days]
• Intra-hospital mortality [Срок оценки: at 90 days]
• Rate of thoracic surgery [Срок оценки: at 30 days]
• Rate of additional intrapleural enzyme therapy [Срок оценки: at 30 days]
• Length of hospital stay [Срок оценки: at 90 days]
• Change in the area of pleural opacity [Срок оценки: at day 3]
• Presence of a restrictive ventilatory defect [Срок оценки: at day 90]
• Assessment of pain using a numeric pain scale [Срок оценки: at 90 days]
• valuation of the prognostic performance of the RAPID score [Срок оценки: at day 0]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU Amiens Picardie — Amiens

Идентификаторы

NCT: NCT07666464 · PI2025_843_0088

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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