Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Severe Pleural Infection: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.
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 complicated pleural infections in adults as defined as complicated parapneumonic effusions or pleural empyema.
详细描述
Pleural infection (empyema or complex parapneumonic effusion [CPPE]) represents one of the common clinical diagnoses encountered in clinical practice in the United States (US) and worldwide. The incidence of pleural infection continues to rise with an annual incidence of approximately 65,000 in the US and United Kingdom (UK). It is associated with substantial morbidity and mortality as well as increased hospital costs despite advances in medical diagnostic and therapeutic strategies. The overall mortality of pleural infection approaches 20% and it is above 30% in elderly patients over 65 years and immunocompromised patients.
Treatment of CPPE or empyema requires antibiotics and drainage of the pleural cavity.3 However, in about 30% of cases, it is difficult to remove the fluid due to loculations, septations and increased viscosity of the pleural fluid, and around 20% will need surgical intervention to adequately treat the pleural infection.
Specific Aim 1:
To compare the efficacy of early medical thoracoscopy versus fibrinolytic therapy (tPA/DNase) in patients with complicated parapneumonic effusions or pleural empyema.
CPPE is defined as non-purulent effusion in a patient with clinical evidence of infection such as fever and/or elevated blood leukocyte count and/or elevated CRP, with pleural fluid pH ≤ 7.2 (measured by blood-gas analyzer), or pleural fluid glucose < 60 mg/dl or pleural fluid LDH >1000 IU/L26. Empyema is defined as pus within the pleural space and/or presence of bacteria on pleural fluid Gram stain or culture.
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
- Single (Outcomes Assessor)
盲法说明
Change in pleural fluid volume on chest CT scan from randomization (day 0) to prior to chest tube removal will be measured by a radiologist blinded to treatment allocation using image J software
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CPPE along with evidence of septated pleural effusion on pleural ultrasonography and/or chest CT scan
排除标准
- •age <18 years;
- •inability to give informed written consent;
- •previous thoracic surgery or thrombolytic therapy for pleural infection;
- •medical thoracoscopy cannot be performed within 48 hours;
- •inability to tolerate procedure due to hemodynamic instability or severe hypoxemia;
- •inability to correct coagulopathy;
- •presence of a homogeneously echogenic effusion on pleural US27 -
研究组 & 干预措施
Thoracoscopy Arm
Consisting of chest thoracoscopy
干预措施: Chest thoracoscopy (Procedure)
Fibrinolytic Therapy Arm
Consisting of chest fibrinolytic therapy
干预措施: Chest fibrinolytic therapy (Procedure)
Fibrinolytic Therapy Arm
Consisting of chest fibrinolytic therapy
干预措施: tPA (Drug)
Fibrinolytic Therapy Arm
Consisting of chest fibrinolytic therapy
干预措施: DNase (Drug)
结局指标
主要结局
Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.
时间窗: 30 days starting on day of admission
Time between initiation of treatment and hospital discharge
次要结局
- Treatment Failure(30 days starting on day of admission)
- Number of Participants With Adverse Events(30 days starting on day of admission)
- Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection(30 days starting on day of admission)
- Mortality(30 days starting on day of admission)
- Duration of Chest Tube(30 days starting on day of admission)