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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03562689
• Other study ID #: 63657
• Status: Suspended
• Start date: March 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 42
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Delirium
• Sepsis
• Sepsis-Associated Encephalopathy
• Septic Encephalopathy

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Glostrup	Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG frequencies	Automatically measurments of frequencies band	Through study completion, an average of 1 year
Primary	MRI	Structural and diffusion tensor imaging sequences	Through study completion, an average of 1 year
Primary	Cognitive test: Verbal-Paired Associates	Assessing explicit episodic memory performance	Through study completion, an average of 1 year
Primary	Cognitive test: Mini-Mental State Examination (MMSE)	neurocognitive function	Through study completion, an average of 1 year
Primary	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