Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiographic improvement in pleural opacity on chest radiograph
研究概览
简要总结
The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in patients with pleural infection.
详细描述
The regimen 10 mg alteplase and 5 mg DNase twice daily that was used in MIST-2 trial is still an empiric choice. The rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg DNase) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The radiologists were blinded to patient identity and intervention timing
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
- •adult patient with age more than 17 year old
- •evidence of complex parapneumonic effusion or empyema; with poor pleural fluid drainage of ≤150 mL after 24 hours of insertion of chest drain
- •clinical evidence of infection such as fever and or elevated C-reactive protein (CRP) or white-cell count
- •complex pleural effusion proven by ultrasound
- •pleural fluid analysis that fulfilled at least one of the characteristics: frank pus, exudative nature (according to light's criteria), gram stain or culture positive, lactate dehydrogenase (LDH) > 1000 U/L, pH < 7.2 and/or glucose level < 3.3mmol/L
排除标准
- •known allergy to pulmozyme or alteplase
- •acute stroke, active bleeding diathesis
- •major surgery in past 5 days
- •previous pneumonectomy on the infected side
- •bronchopleural fistula
- •pregnancy
- •coagulopathy (INR > 2, APTT >100, platelet count < 50,000 cells)
研究组 & 干预措施
Treatment Arm
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Intervention Drug: Combination Alteplase and pulmozyme (DNase)
干预措施: Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg (Drug)
结局指标
主要结局
Radiographic improvement in pleural opacity on chest radiograph
时间窗: Day 7
measured in percentage
次要结局
- White cell count(Day 7)
- length of hospitalisation(upto 30 days)
- pleural fluid volume drained(Day 7)
- the need of surgical referral(upto 30 days)
- changes in inflammatory markers C-Reactive Protein (CRP )(Day 7)
- adverse events post therapy(Day 7)
- mortality rate at day 30 post intervention(30 days)
研究者
Mohamed Faisal Abdul Hamid
Associate Professor
National University of Malaysia