Cognitive Function and Health-related Quality of Life After Neuro-intensive Care: An Observational Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Global cognitive function
研究概览
简要总结
The study will provide information on cognitive impairment and Health related quality of life in patients surviving 12 months after acute brain injury, generate a hypothesis of useful variables to predict cognitive impairment or low levels of HRQoL, and potentially inform interventions for the prevention and treatment of cognitive impairment following neuro-ICU stay.
详细描述
The aim is to 1) measure the frequency and extent of cognitive impairment after acute brain injury at six and 12-months after neuro-Intensive care unit (ICU) admission 2) explore the association between cognitive impairment at six and 12 months after ICU admission with the following potential risk factors: duration of ICU delirium (days), duration of sepsis (days), duration of post traumatic amnesia (days) and the severity of brain injury (initial Glasgow Coma Scale , 3) describe Health related quality of life, functional disability and frailty at six and 12 after ICU admission and 4) explore the association between the functional disability, frailty and health-related quality of life at 12 months after ICU admission
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic brain injury
- •Spontaneous intracranial hemorrhage
- •Ischemic stroke
- •An anticipated stay in the neuro-ICU for 48 hours or longer.
排除标准
- •Persistent coma defined as Richmond Agitation-Sedation Scale (RASS) -5 to -3 throughout the neuro-ICU stay
- •Congenital brain injury
- •Suspected pre-existing Cognitive impairment (Informant Questionnaire on cognitive decline in the elderly (IQCODE): 3.3 or more) (regardless of cause)
- •Permanent residence outside Denmark
- •Inability to communicate in Danish
结局指标
主要结局
Change in Global cognitive function
时间窗: from baseline to 12 months after ICU admission
measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning.
Change in Executive function
时间窗: from baseline to 12 months after ICU admission
measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function
次要结局
- Change in Disability after head injury/nontraumatic acute brain insults II(from baseline to 12 months after ICU admission)
- Change in Frailty(baseline to 12 months after ICU admission)
- Change in Health related quality of life after brain injury(from baseline to 12 months after ICU admission)
- Delirium(during the procedure (ICU stay) up to 30 days)
- Change in Disability after head injury/nontraumatic acute brain insults I(from baseline to 12 months after ICU admission)
研究者
Kirsten Moller
Professor
Rigshospitalet, Denmark