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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2013 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Rikke Malte Nielsen, M.D., Glostrup University Hospital, Copenhagen Identifier:
First received: October 24, 2013
Last updated: November 4, 2013
Last verified: November 2013
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.


Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness

Resource links provided by NLM:

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Comparing electroencephalographic and electrocortical recordings in neurointensive care [ Time Frame: Delirium - a clinical manifestation of cortical spreading depression? ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood, cerebrospinalfluid, urine

Estimated Enrollment: 260
Study Start Date: October 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients with and without acute cerebral trauma

Inclusion Criteria:

  • expected admission in the ICU >24 hours

Exclusion Criteria:

  • Cerebral trauma <6 months
  • existing delirium
  • severe dementia
  Contacts and Locations
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Please refer to this study by its identifier: NCT01980251

Glostrup Hospital, University of Copenhagen Recruiting
Glostrup, Denmark, DK-2600
Contact: Rikke M Nielsen, MD    +45 51 900 551   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Study Director: Kirsten Moller, MD, PhD Department of Neuroanaesthesiology 2093, Rigshospitalet, Denmark
  More Information

Responsible Party: Rikke Malte Nielsen, M.D., M.D., Glostrup University Hospital, Copenhagen Identifier: NCT01980251     History of Changes
Other Study ID Numbers: Delirium and cEEG 
Study First Received: October 24, 2013
Last Updated: November 4, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Glostrup University Hospital, Copenhagen:
Delirium, electroencephalography, CSD

Additional relevant MeSH terms:
Critical Illness
Behavioral Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes processed this record on July 21, 2016