Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 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 complicated 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: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients 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
Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
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
研究组 & 干预措施
Medical Thoracoscopy group
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
干预措施: Medical Thoracoscopy (Procedure)
Fibrinolytic therapy group
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
干预措施: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) (Drug)
结局指标
主要结局
Duration of Hospital Stay After Intervention
时间窗: 12 week follow up period
duration of hospital stay in days from time of procedure to discharge from hospital.
次要结局
- Total Length of Hospital Stay(12 week follow up period)
- Number of Participants Necessitating Intervention After the Assigned Treatment(12 week follow up period)
- Adverse Events(12 week follow up period)
- In Hospital and 30-day Mortality(30 days)
研究者
Fayez Kheir,MD,MSc
MD, MSc
Tulane University