Clinical trial NCT01980251: Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness
Official title: Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium, electroencephalography, CSD
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with and without acute cerebral trauma

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

Eligibility criteria: Inclusion Criteria:

* expected admission in the ICU \>24 hours

Exclusion Criteria:

* Cerebral trauma \<6 months
* existing delirium
* severe dementia

Primary outcomes:
measure: The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU
timeFrame: 7 days
Secondary outcomes:
measure: The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma
timeFrame: Cortical spreading depression in the ICU
Other outcomes:
measure: Comparing electroencephalographic and electrocortical recordings in neurointensive care
timeFrame: Delirium - a clinical manifestation of cortical spreading depression?
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital, University of Copenhagen
Study officials:
affiliation: Department of Neuroanaesthesiology 2093, Rigshospitalet, Denmark
name: Kirsten Moller, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Nielsen RM, Urdanibia-Centelles O, Vedel-Larsen E, Thomsen KJ, Moller K, Olsen KS, Lauritsen AO, Eddelien HS, Lauritzen M, Benedek K. Continuous EEG Monitoring in a Consecutive Patient Cohort with Sepsis and Delirium. Neurocrit Care. 2020 Feb;32(1):121-130. doi: 10.1007/s12028-019-00703-w.