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
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
intrapleural irrigation
Experimental group: 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 twices daily for a total of 6 irrigations.
干预措施: intrapleural irrigation (Drug)
standard care
Control group: Standard care includes pleural drainage with 20 mL 0.9% sodium chloride flushes administered twice daily for 3 days to maintain tube patency. Thoracic suction (up to -20 cmH2O) will be applied to chest tubes.
干预措施: Standard care (Procedure)