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

• ClinicalTrials.gov Identifier: NCT03562689
• Recruitment Status: Suspended
• First Posted: June 19, 2018
• Last Update Posted: March 11, 2020
• Sponsor: Rigshospitalet, Denmark
• Collaborator: University of Copenhagen
• Information provided by (Responsible Party): Olalla Urdanibia Centelles, Rigshospitalet, Denmark

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
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:

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 Design

• Study Type: Observational
• Estimated 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: March 1, 2019
• Estimated Primary Completion Date: August 2020
• Estimated Study Completion Date: December 2020

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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)

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.

Contacts and Locations

Locations

Denmark

Rigshospitalet

Glostrup, Hovedstaden, Denmark, 2600

Sponsors and Collaborators

Rigshospitalet, Denmark

University of Copenhagen

More Information

• Responsible Party: Olalla Urdanibia Centelles, MD; PhD Candidate, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03562689
• Other Study ID Numbers: 63657
• First Posted: June 19, 2018
• Last Update Posted: March 11, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Olalla Urdanibia Centelles, Rigshospitalet, Denmark:

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

Additional relevant MeSH terms:

Delirium; Brain Diseases; Sepsis-Associated Encephalopathy; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases