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

Suspended

• Conditions: Sepsis; Delirium; Septic Encephalopathy

• Registration Number: NCT03562689
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-19
• Study Start: 2019-03-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive test: Verbal-Paired Associates	Through study completion, an average of 1 year	Assessing explicit episodic memory performance
EEG frequencies	Through study completion, an average of 1 year	Automatically measurments of frequencies band
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
MRI	Through study completion, an average of 1 year	Structural and diffusion tensor imaging sequences

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Glostrup, Hovedstaden, Denmark