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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rikke Malte Nielsen, M.D., Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01980251
First received: October 24, 2013
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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.

Condition
Delirium

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

Enrollment: 102
Study Start Date: October 2013
Study Completion Date: September 2015
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
  Eligibility

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
Criteria

Inclusion Criteria:

  • expected admission in the ICU >24 hours

Exclusion Criteria:

  • Cerebral trauma <6 months
  • existing delirium
  • severe dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980251

Locations
Denmark
Glostrup Hospital, University of Copenhagen
Glostrup, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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
ClinicalTrials.gov Identifier: NCT01980251     History of Changes
Other Study ID Numbers: Delirium and cEEG 
Study First Received: October 24, 2013
Last Updated: August 3, 2016
Health Authority: Denmark: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Data analysis is in progress

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

Additional relevant MeSH terms:
Depression
Delirium
Critical Illness
Behavioral Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 23, 2016