EURopean Study on Encephalitis in Intensive CAre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ICUREsearch
- 入组人数
- 596
- 试验地点
- 65
- 主要终点
- Modified Rankin scale score
研究概览
简要总结
Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.
详细描述
Primary objective :
evaluate the correlation between mRs score and the baseline characteristics Functional outcomes will be evaluated using the modified Rankin score (mRS) score, which is one of the most frequently used scores in acute neurological diseases [18]. A poor outcome will be defined by a mRS score > 2 (functional dependence or death). The investigator usually evaluates this score if the patient is still in the hospital 90 days after admission. Patients discharged from hospital within 90 days following ICU admission without major disability (mRS 0, 1 or 2) are considered to have a good outcome. Patients discharged within 90 days with a disability will be classified for the study according to the latest available data. Patients will not be contacted directly by the investigator for the study purposes.
Secondary objectives :
To identify additional prognosis factors : the clinical, radiological, biological and neurophysiological factors associated with poor outcome for patients admitted to the ICU with AE
- Day 28 mortality, in-ICU mortality, in-hospital mortality
- Major systemic complications (septic shock, hyponatremia, nosocomial pneumonia, catheter-related BSI, overt gastroenteral bleeding, pulmonary embolism)
- Major intracranial complications during ICU stay
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
- •non-opposition to participate in the study (or consent if applicable according to local legislation)
- •Impaired consciousness (altered mentation, stupor, or personality changes) for a duration ≥ 24 h, without obvious explanation
- •A score on the Glasgow Coma Scale < or =13 at ICU admission
- •A Cerebrospinal fluid pleocytosis > = 5 cell / mm3
- •At least 2 of the following :
- •Fever (≥ 38.0 °C) within 72 hours before or after admission
- •Generalized or partial seizures non-attributable to pre-existing epilepsy
- •New onset focal neurological deficit
- •Parenchymal abnormalities on MRI compatible with AE
- •EEG alterations compatible with AE.
排除标准
- •CSF or neuroimaging not available (s) or not performed.
- •febrile encephalopathy associated with another diagnosis (sepsis, neurological disease with aspiration pneumonia ... )
结局指标
主要结局
Modified Rankin scale score
时间窗: Day 90
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.
次要结局
- Intracranial complications(Day 90)
- Mortality at Day 28(Day 28)
- Systematic complications(Day 90)
- Intracranial pressure monitoring(Day 90)
- Neurosurgery(Day 90)