Cognitive Function and Health-related Quality of Life After Neuro-intensive Care

Sepsis Clinical Trial

— COGNI  

Official title:

Cognitive Function and Health-related Quality of Life After Neuro-intensive Care: An Observational Multicenter Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04881097
• Other study ID #: NNF 20OC0064760
• Status: Withdrawn
• Start date: August 1, 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: November 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injury
• Amnesia
• Brain Injuries
• Cognitive Dysfunction
• Delirium
• Health-related Quality of Life
• Sepsis

Intervention

Behavioral:
• no intervention
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global cognitive function	measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning.	from baseline to 6 months after ICU admission
Primary	Change in Global cognitive function	measured by The Repeatable Battery for the Assessment of Neuropsychological Status, Overall score (mean 100; SD=15). Higher scores indicate better cognitive functioning.	from baseline to 12 months after ICU admission
Primary	Change in Executive function	measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function	from baseline to 6 months after ICU admission
Primary	Change in Executive function	measured by Trail Making Test B, Score indicate time in seconds to complete task, the higher speed (less seconds) indicates higher executive function	from baseline to 12 months after ICU admission
Secondary	Change in Health related quality of life after brain injury	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.	from baseline to 6 months after ICU admission
Secondary	Change in Health related quality of life after brain injury	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.	from baseline to 12 months after ICU admission
Secondary	Delirium	measured by Confusion measured by CAM-ICU or Intensive Care Delirium Screening Checklist (ICDSC).	during the procedure (ICU stay) up to 30 days
Secondary	Change in Disability after head injury/nontraumatic acute brain insults I	measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability	from baseline to 6 months after ICU admission
Secondary	Change in Disability after head injury/nontraumatic acute brain insults I	measured by Glasgow outcome scale extended (GOSE). Scores from 1 to 8, higher scores indicate less disability	from baseline to 12 months after ICU admission
Secondary	Change in Disability after head injury/nontraumatic acute brain insults II	measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability	from baseline to 6 months after ICU admission
Secondary	Change in Disability after head injury/nontraumatic acute brain insults II	measured by Extended disability rating scale (DRS). Scores from 0 to 29, the higher the score the more disability	from baseline to 12 months after ICU admission
Secondary	Change in Frailty	measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail).	baseline to 6 months after ICU admission
Secondary	Change in Frailty	measured by the Clinical Frailty Scale (CFS). Scale is from 1 to 9 ( the higher score the more frail).	baseline to 12 months after ICU admission