2026-526289-25-00招募中4 期
VATS or Intrapleural Enzymatic Therapy for patientS with empyema (the VIETS trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 11
- 主要终点
- Length of hospital stay (LOS) during the first 30 days.
研究概览
简要总结
To provide decisive evidence on which treatment modality results in a shorter length of hospital stay (LOS) for patients with a parapneumonic pleural infection not responding to initial treatment with antibiotics and chest tube drainage.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years with pneumonia and suspected parapneumonic pleural infection, evidenced by (both obligatory) pleural fluid which is either purulent, gram stain or culture positive, acidic (pH<7.2), low in glucose (<2 mmol/L) and radiological suspicion of parapneumonic pleural infection
- •Fit for surgery (ie able to be ventilated on one lung during the procedure).
- •Failure of standard care (consisting of a chest tube and antibiotics) as judged by the treating physician ≤ 24 h after chest tube insertion (considering radiology, insufficient decrease of inflammatory markers, clinical status of the patient)
- •Able to provide informed consent
排除标准
- •Patients not fit for surgery.
- •Patients requiring direct surgery (e.g. dry tap)
- •Need for more than two chest tubes at presentation.
- •Any contraindication to IET (bleeding risk, allergy).
- •A parapneumonic pleural infection with another cause than a pneumonia
- •Previous treatment of a parapneumonic pleural infection <1 year ago, a history of pulmonary surgery on the same side of the parapneumonic pleural infection.
- •Life expectancy <3 months and/or suffer from a terminal illness.
- •Patients who are pregnant or lactating (pregnancy status will be confirmed prior to randomisation for woman of childbearing potential).
- •Patients with a suspected or confirmed bronchopleural fistula.
研究组 & 干预措施
Pulmozyme 2500 E/2,5 ml, verneveloplossing
Test
干预措施: Pulmozyme 2500 E/2,5 ml, verneveloplossing (Drug)
Actilyse 20 mg, poeder en oplosmiddel voor oplossing voor injectie en infusie
Test
干预措施: Actilyse 20 mg, poeder en oplosmiddel voor oplossing voor injectie en infusie (Drug)
结局指标
主要结局
Length of hospital stay (LOS) during the first 30 days.
Length of hospital stay (LOS) during the first 30 days.
次要结局
- Measures related to treatment (duration of chest tube drainage, delayed discharge days, re-intervention and re-admission rates, morbidity, mortality, type and duration of antibiotic treatment and pain medication).
- Patient reported outcomes (pain, health related quality of life, limitations in daily activities, return to work).
- Economic evaluation (healthcare costs, costs of patient, costs of productivity loss, health related quality of life).
研究者
Dr. Josje Altenburg
Scientific
Amsterdam UMC Stichting
研究点 (11)
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