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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Suspended

CT.gov ID

NCT03562689

Collaborator

University of Copenhagen (Other)

Enrollment

Location

21.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Septic Encephalopathy Delirium Sepsis	Other: Delirium and with septic encephalopathy.

Detailed Description

The overall aim is to understand the pathophysiological mechanism in delirium and septic encephalopathy and its consequences.

For this purpose we will:

Provide extensive cognitive testing. These results provide the basis for categorization of patients surviving septic encephalopathy and delirious patients.
First, the investigators will examine if the differences in cognitive function is reflected in the ability of the brain to generate high-frequency electrical oscillations that accompany and underlie perception, attention, cognition, memory formation and retrieval. It will be performed by carrying out continuous EEG (cEEG) and by examination of steady-state evoked cognitive EEG responses.
Second, the investigations will examine MRI, structural and diffusion tensor imaging sequences. Hippocampal, thalamic, amygdala, lentiform nucleus and cingulate cortex volumes will be determined bilaterally and will be compared between individuals with healthy brain aging and patients that survived delirium.
Third, the investigators will assess plasma markers of free radical production.

Study Design

Study Type:

Observational

Anticipated Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Outcome Measures

Primary Outcome Measures

EEG frequencies [Through study completion, an average of 1 year]
Automatically measurments of frequencies band
MRI [Through study completion, an average of 1 year]
Structural and diffusion tensor imaging sequences
Cognitive test: Verbal-Paired Associates [Through study completion, an average of 1 year]
Assessing explicit episodic memory performance
Cognitive test: Mini-Mental State Examination (MMSE) [Through study completion, an average of 1 year]
neurocognitive function
Cognitive test: Trail-Making Test and the Symbol-Digit Modalities Test (SDMT), [Through study completion, an average of 1 year]
Speed of processing and executive functioning

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for the ICU cohort:

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

Exclusion Criteria for the ICU cohort:

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