Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 7
- 主要终点
- IET Failure: Surgery and/or mortality at 90 days
研究概览
简要总结
The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.
The investigators are trying to learn:
- Does using the medicine once a day work just as well as using it twice a day?
- Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?
- Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?
Participants will:
- Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.
- Be asked to give permission to join the study.
- Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.
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
- •Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.
- •Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- •Age ≥ 18 years at the time of consent.
- •Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET
- •Pleural fluid that is one of the following:
- •(i) Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) < 7.2 (iii) Pleural fluid glucose < 60mg/dL (iv) Pleural fluid Lactate Dehydrogenase (LDH) > 1,000 IU/L
- •Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement
排除标准
- •Known pregnancy or lactating females
- •Prisoners
- •Age <18 years at time of consent
- •Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
- •Known sensitivity or allergic reaction to DNAse or tPA
- •Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days
- •Previous pneumonectomy or active bronchopleural fistula on the affected side
- •Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration
- •Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection
研究组 & 干预措施
Once daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.
干预措施: DNA degradation once daily (Drug)
Once daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.
干预措施: Fibrinolytic once daily (Drug)
Twice daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) twice daily for 3 consecutive days.
干预措施: Fibrinolytic twice daily (Drug)
Twice daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) twice daily for 3 consecutive days.
干预措施: DNA degradation twice daily (Drug)
结局指标
主要结局
IET Failure: Surgery and/or mortality at 90 days
时间窗: 90 days
Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.
IET Failure: Surgery and/or mortality at 90 days
时间窗: 90 days
Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.
次要结局
- Change in C-reactive Protein (CRP) level(From enrollment until day 3 of intervention)
- Chest tube drainage amount(From enrollment until day 3 of intervention)
- Duration of chest tube placement(90 days)
- 30 Day Mortality(30 days)
- Hospital length of stay(90 days)
- Oral Morphine Equivalents (OME)(From enrollment until day 3 of intervention)
- Change of White Blood Cell Count(From enrollment until day 3 of intervention)
- 30 Day Mortality(30 days)
- Hospital length of stay(90 days)
- Oral Morphine Equivalents (OME)(From enrollment until day 3 of intervention)
- Change of White Blood Cell Count(From enrollment until day 3 of intervention)
- Change in C-reactive Protein (CRP) level(From enrollment until day 3 of intervention)
- Change in Fever(From enrollment until day 3 of intervention)
- Chest tube drainage amount(From enrollment until day 3 of intervention)
- Duration of chest tube placement(90 days)
- Difference in pleural opacification on chest x-ray imaging between once daily IET and twice daily IET(From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy)
- Percent of participants who have pleural hemorrhage requiring blood transfusion(From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy)