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Completed

NCT Number: NCT01980251

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

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glostrup Hospital, University of Copenhagen

Glostrup Municipality, DK-2600, Denmark

About this study

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

  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • expected admission in the ICU >24 hours

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU

    Time frame: 7 days

Secondary outcomes

  1. The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma

    Time frame: Cortical spreading depression in the ICU

Other outcomes

  1. Comparing electroencephalographic and electrocortical recordings in neurointensive care

    Time frame: Delirium - a clinical manifestation of cortical spreading depression?

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 8, 2013
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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