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

2026年6月30日更新者：Centre Hospitalier Universitaire, Amiens

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

244

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Damien BASILLE, Pr
电话号码：33+3 22 45 59 10
邮箱：basille.damien@chu-amiens.fr

学习地点

法国
- Picardie
  - Amiens、Picardie、法国、80054
    - 招聘中
    - CHU Amiens Picardie
    - 首席研究员：
      
      Christophe GUT-GOBERT, MD
    - 首席研究员：
      
      Hugues MOREL, MD
    - 首席研究员：
      
      Frédéric GAGNADOUX, MD
    - 接触：
      
      Damien BASILLE, Dr
      
      邮箱：basille.damien@chu-amiens.fr
    - 首席研究员：
      
      Elise NOELSAVINA, MD
    - 首席研究员：
      
      Camille PIRIOU-GAROUTE, MD
    - 首席研究员：
      
      Gilles MANGIAPAN, MD
    - 首席研究员：
      
      Thomas FLAMENT, MD
    - 首席研究员：
      
      Vincent DUCROCQ, MD
    - 首席研究员：
      
      Laure SEYER, MD
    - 首席研究员：
      
      Elise ARTAUD-MACARI, MD
    - 首席研究员：
      
      Ibrantina LUCENA, MD
    - 首席研究员：
      
      Marine GOSSET-WOIMANT, MD
    - 首席研究员：
      
      Cherifa GOUNANE, MD
    - 首席研究员：
      
      Marion DESQUIENS, MD
    - 首席研究员：
      
      Charles- Hugo MARQUETTE, MD
    - 首席研究员：
      
      Laure GOUBERT, MD
    - 首席研究员：
      
      Nina DE MONTMOLLIN, MD
    - 首席研究员：
      
      Xavier DEMANT, MD
    - 首席研究员：
      
      Vincent IOOS, MD
    - 首席研究员：
      
      Maxime FURSTENBERGER, MD
    - 首席研究员：
      
      Jean MORIN, MD
    - 首席研究员：
      
      Asaël BERGER, MD
    - 首席研究员：
      
      Antoine DUMAZET, MD
    - 首席研究员：
      
      Lidia PETIT, MD
    - 首席研究员：
      
      Jean STAENTZEL, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：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.
有源比较器：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.	程序：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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Number of treatment failure 大体时间：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.	at 30 days

次要结果测量

结果测量	措施说明	大体时间
Volume of pleural fluid drained from randomization 大体时间：at day 3	Volume of pleural fluid drained from randomization to day 3	at day 3
Incidence of adverse events 大体时间：at 90 days	Incidence of serious and non-serious adverse events, including fever, allergic reactions, bleeding, and chest tube obstruction	at 90 days
Intra-hospital mortality 大体时间：at 30 days		at 30 days
Intra-hospital mortality 大体时间：at 90 days		at 90 days
Rate of thoracic surgery 大体时间：at 30 days	Rate of thoracic surgery	at 30 days
Rate of additional intrapleural enzyme therapy 大体时间：at 30 days	Rate of additional intrapleural enzyme therapy	at 30 days
Length of hospital stay 大体时间：at 90 days	Length of hospital stay	at 90 days
Change in the area of pleural opacity 大体时间：at day 3	Change in the area of pleural opacity, measured as the percentage of the ipsilateral hemithorax occupied by effusion on chest radiography from randomization to day 3;	at day 3
Presence of a restrictive ventilatory defect 大体时间：at day 90	Presence of a restrictive ventilatory defect, defined as total lung capacity < 80% of predicted values	at day 90
Assessment of pain using a numeric pain scale 大体时间：at 90 days	Assessment of pain using a numeric pain scale	at 90 days
valuation of the prognostic performance of the RAPID score 大体时间：at day 0	valuation of the prognostic performance of the RAPID score	at day 0