Clinical trial NCT03562689: Cognitive Processing in Patients Surviving Delirium. Neuropsychological, EEG and Structural Brain Correlates.
Official title: Cognitive Processing in Patients Surviving Delirium. Neuropsychological, EEG and Structural Brain Correlates.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Septic Encephalopathy
Delirium
Sepsis
Keywords: Sepsis
Encephalopathy
Delirium
ICU
EEG
MRI
Cognitive tests
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2018-06-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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).

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

For this purpose we will:

1. Provide extensive cognitive testing. These results provide the basis for categorization of patients surviving septic encephalopathy and delirious patients.
2. 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.
3. 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.
4. Third, the investigators will assess plasma markers of free radical production.

Eligibility criteria: 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.

Primary outcomes:
measure: EEG frequencies
timeFrame: Through study completion, an average of 1 year
measure: MRI
timeFrame: Through study completion, an average of 1 year
measure: Cognitive test: Verbal-Paired Associates
timeFrame: Through study completion, an average of 1 year
measure: Cognitive test: Mini-Mental State Examination (MMSE)
timeFrame: Through study completion, an average of 1 year
measure: Cognitive test: Trail-Making Test and the Symbol-Digit Modalities Test (SDMT),
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet
state: Hovedstaden
Study officials:
References: