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

NCT04881097 | Withdrawn DMC

• 1 other identifier: NNF 20OC0064760
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (9)

• Change in Health related quality of life after brain injury

  from baseline to 6 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 6 months after ICU admission

• Change in Disability after head injury/nontraumatic acute brain insults I

  from baseline to 12 months after ICU admission

Interventions

no intervention BEHAVIORAL

no intervention

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Traumatic brain injury
• Spontaneous intracranial hemorrhage
• Ischemic stroke
• An anticipated stay in the neuro-ICU for 48 hours or longer.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction; Delirium; Sepsis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Suzanne F Herling, Ph.D

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 11, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share