Cognitive Processing in Patients Surviving Delirium. Neuropsychological, EEG and Structural Brain Correlates.

NCT03562689 | Suspended

• 1 other identifier: 63657
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The research program explores how delirium influenced brain function in patients surviving delirium and septic encephalopathy from a non neurological specialized ICU cohort from 2013 to 2015 in Rigshospitalet (Glostrup).

Conditions

Septic Encephalopathy; Delirium; Sepsis

Keywords

Sepsis; Encephalopathy; Delirium; ICU; EEG; MRI; Cognitive tests

Outcome Measures

Primary Outcomes (5)

• EEG frequencies

  Automatically measurments of frequencies band

  Through study completion, an average of 1 year

• MRI

  Structural and diffusion tensor imaging sequences

  Through study completion, an average of 1 year

• Cognitive test: Verbal-Paired Associates

  Assessing explicit episodic memory performance

  Through study completion, an average of 1 year

• Cognitive test: Mini-Mental State Examination (MMSE)

  neurocognitive function

  Through study completion, an average of 1 year

• Cognitive test: Trail-Making Test and the Symbol-Digit Modalities Test (SDMT),

  Speed of processing and executive functioning

  Through study completion, an average of 1 year

Interventions

Delirium and with septic encephalopathy. OTHER

Delirium or septic encephalopathy survivors will be analized in the same way: Cognitive tests, EEG and MRI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Survivors of the critical ill cohort which were included the ones without known acute central nervous system affection admitted to a medical ICU with sepsis or septic shock, mono- or multi organ failure (respiratory insufficiency, circulatory shock, hepatic and/or renal failure) as indicated by a need for invasive or non-invasive mechanical ventilation, vasoactive drugs and/or CRR)

You may qualify if:

• Age \>18 years;
• Length of stay \>24 hours in the ICU.

You may not qualify if:

• Expected death \<24 hours;
• Psychiatric illness; pre-existing delirium; severe dementia; cerebrovascular event \<six months; major surgery \<two months;
• Non-Danish or English speaking.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

Rigshospitalet

Glostrup Municipality, Capital Region, 2600, Denmark

Location

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy; Delirium; Sepsis; Brain Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD Candidate

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: March 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

DK (1)