2025-524697-42-00招募中3 期
EPISSOC : Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standard of Care for the management of complicated pleural infections
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 26
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized controlled trial comparing an Early Pleural Irrigation strategy with Saline to the Standa
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old)
- •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.
排除标准
- •Tuberculous pleural effusions.
- •Previous treatment with intrapleural fibrinolytic agents (urokinase, streptokinase, alteplase, or DNase) or intrapleural saline lavage.
- •Pregnancy or lactation.
- •Expected survival of less than 3 months, owing to a pathologic condition other than that responsible for the pleural abnormalities.
- •Thoracic drainage since more than 24h
- •Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
研究者
BASILLE Damien
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (26)
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