适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- BioMérieux
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- immune cells patterns in VAP
研究概览
简要总结
objective of LUNG-I3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (BAL) fluid after an infection, with a special focus on alveolar macrophages and neutrophils
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •All the following criteria
- •Age 18 years or greater
- •Severe ICU patients hospitalized for one of the above diseases:
- •Septic shock (requirement of vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia) caused either by pneumonia (n=20) or another source n=20)
- •Severe trauma (level I and II), Injury Severity Score ≥ 25 OR
- •Burn with TBSA over 20%
- •NAD > 0.1 µg/kg/min
- •At least 2 SOFA criteria ≥ 2 points
排除标准
- •Aspiration pneumonia
- •Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this includes in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1121-8 of the French Public Health Code.)
- •Smoke inhalation in burn patients
- •Participation in an intervention study
- •Pregnant or breastfeeding women
- •Immunocompromised patients, defined as
- •patients with solid tumors with chemotherapy in the last 3 months or a progressive metastatic disease
- •hematologic malignancies
- •solid organ transplantation
- •HIV infection with or without AIDS
- •treatment with corticosteroids (> 3 months at any dosage or ≥ 1 mg/kg prednisone equivalent per day for > 7 day)
- •treatment with other immunosuppressive drugs.
结局指标
主要结局
immune cells patterns in VAP
时间窗: before and at time of VAP diagnosis
The primary endpoint will be to describe and compare the distribution of immune cells within the lung and the blood before VAP diagnosis (VAP prediction) and at the time of VAP diagnosis.
次要结局
未报告次要终点
研究者
研究点 (1)
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