Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness

Completed

• Conditions: Delirium

• Registration Number: NCT01980251
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to 80 % of patients. It is associated with significantly increased morbidity and mortality during admission and post-discharge. The mechanism behind the condition is poorly understood but assumably multifactorial, and the purpose of this study is to investigate the pathophysiology further.

Detailed Description

The pathophysiology behind delirium in critical illness is not clarified but assumed to involve inflammation, changes in cerebral perfusion and neurotransmission, sleep deprivation and the use of i.e. sedatives.

Cortical spreading depression is a phenomenon occuring in critically ill patients with acute cerebral trauma and likely associated with significant secondary neuron damage.

The hypothesis is that

1. Delirium in critically ill patients without acute cerebral damage is a clinical manifestation of cortical spreading depression and can be recorded in a noninvasive direct current-electroencephalography

2. Electroencephalographic alterations or potentially specific signatures occur in delirium and thus, delirium can be predicted by recording continuous alternate current electroencephalography on admission in an ICU

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• expected admission in the ICU >24 hours

Exclusion Criteria

• Cerebral trauma <6 months
• existing delirium
• severe dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU	7 days

Secondary Outcome Measures

Name	Time	Method
The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma	Cortical spreading depression in the ICU

Trial Locations

Locations (1)

Glostrup Hospital, University of Copenhagen; 🇩🇰 Glostrup, Denmark