Neurological Abnormalities in SARS-CoV-2 ICU Patients. A Prospective Study. NeuroCOVID Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dosage of biomarkers typically explored in intensive care unit delirium
研究概览
简要总结
The SARS-CoV-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. After an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. This encephalopathy state remains, to date and to our knowledge, unexplained. Clinical features do not appear to fully correlate with regular delirium. This encephalopathy might be explained by deep and prolonged hypoxemia, a wide use of sedation drugs, systemic inflammation or the hostile ICU environment.
详细描述
This study is intended to investigate neurological abnormalities associated with SARS-CoV-2 infection. Complete daily neurological examinations will be routinely conducted in intensive care unit patients. Specific biological analyses will also be performed in these patients by collecting additional blood samples from an arterial or central catheter, every 2 days. These clinical and biological examinations will be continued throughout patient's stay in the intensive care unit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥ 18 years old
- •COVID-19 positive patient (positive RT PCR, nasopharyngeal or tracheal)
- •Patient admitted in an intensive care unit of the department of Anesthesia, Critical Care and Perioperative of Clermont-Ferrand University Hospital
- •Patient with an arterial or central catheter to perform blood samples collection
排除标准
- •Patient or family member's refusal to participate
- •Neuropsychiatric history that may interfere with neurological evaluations in the intensive care unit
- •Patient not affiliated with French social security insurance
- •Patient under legal guardianship
结局指标
主要结局
Dosage of biomarkers typically explored in intensive care unit delirium
时间窗: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Plasminogen activator inhibitor-1 (PAI-1), E-selectin and angiopoietin-2
Dosage of neuronal injury markers
时间窗: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
S100 β, Neuron Specific Enolase (NSE), GFAP, UCHL1, NFL
次要结局
- Coma assessment(Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days)
- Neurological abnormalities(Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days)
- Pupils characteristics(Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days)
- Delirium assessment(Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days)