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

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).

Study Overview

• Status: Suspended
• Conditions: Sepsis; Delirium; Septic Encephalopathy
• Intervention / Treatment: 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:

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.

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Study Locations

• Denmark
  • Hovedstaden
    • Glostrup, Hovedstaden, Denmark, 2600
      • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: MRI; ICU; EEG; Sepsis; Delirium; Encephalopathy; Cognitive tests
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Brain Diseases; Sepsis-Associated Encephalopathy
• Other Study ID Numbers: 63657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: EEG, cognitive tests and MRI could be available for other researchers in the field.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No