Clinical trial NCT04881097: Cognitive Function and Health-related Quality of Life After Neuro-intensive Care
Official title: Cognitive Function and Health-related Quality of Life After Neuro-intensive Care: An Observational Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Brain Injury
Cognitive Dysfunction
Delirium
Sepsis
Post-traumatic Amnesia
Health-related Quality of Life
Keywords: Acute brain injury after intensive care unit care
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Aarhus University Hospital
name: Odense University Hospital
First posted: 2021-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with acute brain injury from traumatic brain injury, spontaneous intracranial hemorrhage, or ischemic stroke with a Neuro ICU stay

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Global cognitive function
timeFrame: from baseline to 6 months after ICU admission
measure: Change in Global cognitive function
timeFrame: from baseline to 12 months after ICU admission
measure: Change in Executive function
timeFrame: from baseline to 6 months after ICU admission
measure: Change in Executive function
timeFrame: from baseline to 12 months after ICU admission
Secondary outcomes:
measure: Change in Health related quality of life after brain injury
timeFrame: from baseline to 6 months after ICU admission
measure: Change in Health related quality of life after brain injury
timeFrame: from baseline to 12 months after ICU admission
measure: Delirium
timeFrame: during the procedure (ICU stay) up to 30 days
measure: Change in Disability after head injury/nontraumatic acute brain insults I
timeFrame: from baseline to 6 months after ICU admission
measure: Change in Disability after head injury/nontraumatic acute brain insults I
timeFrame: from baseline to 12 months after ICU admission
measure: Change in Disability after head injury/nontraumatic acute brain insults II
timeFrame: from baseline to 6 months after ICU admission
measure: Change in Disability after head injury/nontraumatic acute brain insults II
timeFrame: from baseline to 12 months after ICU admission
measure: Change in Frailty
timeFrame: baseline to 6 months after ICU admission
measure: Change in Frailty
timeFrame: baseline to 12 months after ICU admission
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Suzanne F Herling, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: