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

NCT ID: NCT01980251

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-09-30

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

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• expected admission in the ICU >24 hours

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Rikke Malte Nielsen, M.D.

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Moller, MD, PhD

Role: STUDY_DIRECTOR

Department of Neuroanaesthesiology 2093, Rigshospitalet, Denmark

Locations

Glostrup Hospital, University of Copenhagen

Glostrup Municipality, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30891696 (View on PubMed)

Other Identifiers

Delirium and cEEG

Identifier Type: -

Identifier Source: org_study_id