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

Delirium Clinical Trial

Official title:

Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980251
• Other study ID #: Delirium and cEEG
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: August 3, 2016
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• expected admission in the ICU >24 hours

Exclusion Criteria:

• Cerebral trauma <6 months

• existing delirium

• severe dementia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Delirium
• Depression

Locations

Country	Name	City	State
Denmark	Glostrup Hospital, University of Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparing electroencephalographic and electrocortical recordings in neurointensive care		Delirium - a clinical manifestation of cortical spreading depression?	No
Primary	The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU		7 days	No
Secondary	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	No