Acute Brain Injury, Cognitive Dysfunction, Delirium, Health-related Quality of Life, Post-traumatic Amnesia, Sepsis
Conditions
Keywords
Acute brain injury after intensive care unit care
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALno intervention
no intervention
Sponsors
Aalborg University Hospital
Aarhus University Hospital
Odense University Hospital
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic brain injury * Spontaneous intracranial hemorrhage * Ischemic stroke * An anticipated stay in the neuro-ICU for 48 hours or longer.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global cognitive function | from baseline to 6 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 | from baseline to 6 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability after head injury/nontraumatic acute brain insults I | from baseline to 6 months after ICU admission | measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability |
| Change in Health related quality of life after brain injury | from baseline to 6 months after ICU admission | measured with a disease specific questionnaire:Quality of Life after Brain Injury overall scale (QOLIBRI-OS). Scores are from 0-100, the higher the score the more quality of life. |
| Change in Frailty | baseline to 6 months after ICU admission | measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail). |
| Change in Disability after head injury/nontraumatic acute brain insults II | from baseline to 6 months after ICU admission | measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability |
| Delirium | during the procedure (ICU stay) up to 30 days | measured by Confusion measured by CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC). |
Outcome results
None listed