Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Change in HBP concentration over time
研究概览
简要总结
The purpose of this study is to evaluate different peptide biomarkers, variations in the microbiome and patterns in the bacterial transcriptome as prognostic or diagnostic biomarkers of VAP.
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
- •Admission to an intensive care unit
- •Intubation within last 24 hours
- •Anticipated mechanical ventilation of at least 48 hours
排除标准
- •FiO2 above 70% or PEEP above 15
- •Severe coagulopathy (spontaneous PK(INR) >1.8 or thrombocytes <50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors/NOAC is not an exclusion criteria. If higher doses of these substances are administered, the responsible clinician should be consulted before sample collection.
- •Ongoing infection of the lungs at admission to the ICU.
- •Severely elevated or instable intracranial pressure.
结局指标
主要结局
Change in HBP concentration over time
时间窗: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
Change in concentration (ng/ml) compared to baseline.
Change in IL-26 over time
时间窗: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.
Change in concentration (ng/ml) compared to baseline.
IL-26 at VAP diagnosis
时间窗: VAP day 1 compared to No VAP day 3
Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
HBP at VAP diagnosis
时间窗: VAP day 1 compared to No VAP day 3
Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
次要结局
- Bacterial transcriptome patterns(VAP day 1)
- Diversity of microbiome(Day 1 and 3, and VAP day 1.)