Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-13 @ 1:04 PM
Study NCT ID:
NCT01980251
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness
Sponsor:
Glostrup University Hospital, Copenhagen
Organization:
Study Overview
Official Title:
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: