Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum Neuroinflammation biomarkers in patients developing delirium.
研究概览
简要总结
With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain structural and functional alterations (using brain fMRI).
详细描述
Pathophysiology of delirium is poorly understood; neuroinflammation and brain network disruption are claimed as possible causes of delirium.
The authors want to clarify the role of the alterations of different cellular components of neuroinflammation (neurons, glial cells, and endothelium) in delirium development. Moreover, the authors want to understand whether the neuroinflammation process could cause permanent structural and functional brain damage.
In a nested cross-sectional longitudinal case-control observational study in ICU admitted patients.
The objectives of the studies are as follow: 1) Neuroinflammation biomarkers evaluation in non-neurological ICU patients who develop delirium during ICU-stay (case) compared to matched non-delirious ICU patients (control), and 2) their correlation with brain structural and functional alterations evaluated with a resting-state fMRI protocol and PET.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 patients admitted that would be expected to stay in ICU for at least 3 days
排除标准
- •Acute neurological condition
- •Chronic neurological condition (i.e., seizures, stroke, muscular illness).
- •Hematological malignancy or immunological disease.
- •Blood transfusion in the last 2 weeks
- •Ongoing sedation
- •Any condition which contraindicates MRI execution (presence of non-compatible devices or hemodynamic or respiratory instability).
结局指标
主要结局
Serum Neuroinflammation biomarkers in patients developing delirium.
时间窗: 15 days
Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium.
次要结局
- Correlation between biomarkers alterations and fMRI alterations(15 days)
- fMRI alteration(6 months)
研究者
Piva Simone
Assistant Professor
Università degli Studi di Brescia