Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Duration of hospital stay after intervention
研究概览
简要总结
The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion (CPPE) in adults.
详细描述
Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.
Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy
Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic Therapy group.
Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting
Primary Outcome: Duration of hospital stay after intervention
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
- •Subjects >18 years old with:
- •Evidence of empyema or complex parapneumonic effusion
排除标准
- •Age <18 years
- •Pregnancy
- •Inability to give informed written consent
- •Previous thoracic surgery or thrombolytic therapy for pleural infection
- •Medical thoracoscopy cannot be performed within 48 hours
- •Hemodynamic instability or severe hypoxemia
- •Non corrected coagulopathy
- •Homogeneously echogenic effusion on pleural ultrasonography
结局指标
主要结局
Duration of hospital stay after intervention
时间窗: 12 week follow up period
Number of days hospitalized
次要结局
- Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software(12 week follow up period)
- Number of days with chest drainage(12 week follow up period)
- Total length of hospital stay(12 week follow up period)
- Failure rate of assigned treatment necessitating intervention(12 week follow up period)
- Adverse events(12 week follow up period)
- In hospital and 30-day mortality(30 days)
- Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively(at randomization and at 6 and12 week follow up visit)
- Total costs of each treatment modality(6 and 12 week follow up period)
研究者
Adnan Majid
MD FCCP
Beth Israel Deaconess Medical Center