ISRCTN65937227已完成未知
A randomised controlled trial of biomarker-based exclusion of ventilator-associated pneumonia to improve antibiotic stewardship
ewcastle Upon Tyne Hospitals NHS Trust and University of Newcastle Upon Tyne (UK)0 个研究点目标入组 159 人开始时间: 2013年8月22日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 159
研究概览
简要总结
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27422026 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27974525 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31810865 (added 09/12/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 27/11/2013:
- •1. Age 18 years or over
- •2. Mechanically ventilated for 48hrs
- •3. New or worsening changes on chest x-ray or CT scan of the lungs
- •4. Two or more from:
- •4.1. Temperature <35ºC or >38ºC
- •4.2. Blood white cell count <4x10*9/L or >11x10*9/L
- •4.3. Purulent tracheal secretions
- •5. The patient is considered suitable for early discontinuation of antibiotics
- •Target Gender: Male & Female ; Lower Age Limit 18 years
- •Previous inclusion criteria:
- •1. Age 18 years or over
- •2. Intubated and mechanically ventilated for 48 hrs
- •3. New or worsening changes on chest x-ray or CT scan of the lungs
- •4. Two or more from:
- •4.1. Temperature <35ºC or >38ºC
- •4.2. Blood white cell count <4x10*9/L or >11x10*9/L
- •4.3. Purulent tracheal secretions
- •Target Gender: Male & Female ; Lower Age Limit 18 years
排除标准
- •1. PaO2 <8kPa on FiO2 >0.7
- •2. Positive end-expiratory pressure >15 cmH2O
- •3. Peak airway pressure >35 cmH2O
- •4. Heart rate >140 bpm
- •5. Mean arterial pressure <65 mmHg
- •6. Bleeding diathesis (including platelet count <20x10*9 per litre of blood or international normalised ratio (INR) >3)
- •7. Poorly controlled intracranial pressure (>20 mmHg)
- •8. ICU consultant deems procedure not to be safe
- •9. Previous BAL as part of this study
- •10. Consent declined
- •* Patients who are enrolled in observational studies will be eligible for co-enrolment. Co-enrolment with interventional studies will be possible following consideration of any scientific or statistical interaction, in accordance with current UK Critical Care Research Forum (UKCCRF) recommendations (see appendix). Until coenrolment
- •is considered appropriate for a particular study, patients enrolled in an interventional trial will not be included.
研究者
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