DeliriumNCT01980251
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness
An observational study of Delirium, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Sep 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with and without acute cerebral trauma
Who may be able to join
- expected admission in the ICU >24 hours
Who cannot join
- Cerebral trauma <6 months
- existing delirium
- severe dementia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup Hospital, University of Copenhagen
Glostrup Municipality, DK-2600
About this study
Official title: Delirium, Electroencephalographic Alterations and Cortical Spreading Depression 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.
Read the 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
- 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
- Conditions
- Delirium
- Keywords
- Delirium, electroencephalography, CSD
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU
Measured: 7 days
Secondary outcomes (1)
The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma
Measured: Cortical spreading depression in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Malte Nielsen, M.D., Glostrup University Hospital, Copenhagen
- Investigators
- Kirsten Moller, MD, PhD, Study director, Department of Neuroanaesthesiology 2093, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980251
- Sponsor's protocol ID
- Delirium and cEEG
- Status last verified
- Aug 2016
- First submitted
- 24 Oct 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data analysis is in progress
Publications
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.
PubMed 30891696
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness
- ClinicalTrials.gov ID
- NCT01980251
- Acronym / sponsor ID
- Delirium and cEEG
- Conditions
- Delirium
- Keywords
- Delirium, electroencephalography, CSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with and without acute cerebral trauma
Key inclusion criteria (1 listed)
- expected admission in the ICU >24 hours
Key exclusion criteria (3 listed)
- Cerebral trauma <6 months
- existing delirium
- severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU
Time frame: 7 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Derived from this study: PubMed 30891696Nielsen 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.
- Individual participant dataSharing planned: Undecided. Data analysis is in progress
Related trials for Delirium
RecruitingObservational study
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Delirium - Postoperative, Cardiac Surgery
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Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Moller, MD, PhD study director
Department of Neuroanaesthesiology 2093, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.