Septic EncephalopathyNCT03562689
Cognitive Processing in Patients Surviving Delirium. Neuropsychological, EEG and Structural Brain Correlates.
An observational study of Septic Encephalopathy and Delirium, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The research program explores how delirium influenced brain function in patients surviving delirium and septic encephalopathy from a non neurological specialized ICU cohort from 2013 to 2015 in Rigshospitalet (Glostrup). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Encephalopathy, Delirium, Sepsis
- What is being tested?
- Delirium and with septic encephalopathy.
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Survivors of the critical ill cohort which were included the ones without known acute central nervous system affection admitted to a medical ICU with sepsis or septic shock, mono- or multi organ failure (respiratory insufficiency, circulatory shock, hepatic and/or renal failure) as indicated by a need for invasive or non-invasive mechanical ventilation, vasoactive drugs and/or CRR)
Who may be able to join
- Age >18 years;
- Length of stay >24 hours in the ICU.
Who cannot join
- Expected death <24 hours;
- Psychiatric illness; pre-existing delirium; severe dementia; cerebrovascular event <six months; major surgery <two months;
- Non-Danish or English speaking.
Trial locations and contacts
1 site in 1 country.
About this study
The research program explores how delirium influenced brain function in patients surviving delirium and septic encephalopathy from a non neurological specialized ICU cohort from 2013 to 2015 in Rigshospitalet (Glostrup).
Read the detailed description
The overall aim is to understand the pathophysiological mechanism in delirium and septic encephalopathy and its consequences.
For this purpose we will:
- Provide extensive cognitive testing. These results provide the basis for categorization of patients surviving septic encephalopathy and delirious patients.
- First, the investigators will examine if the differences in cognitive function is reflected in the ability of the brain to generate high-frequency electrical oscillations that accompany and underlie perception, attention, cognition, memory formation and retrieval. It will be performed by carrying out continuous EEG (cEEG) and by examination of steady-state evoked cognitive EEG responses.
- Second, the investigations will examine MRI, structural and diffusion tensor imaging sequences. Hippocampal, thalamic, amygdala, lentiform nucleus and cingulate cortex volumes will be determined bilaterally and will be compared between individuals with healthy brain aging and patients that survived delirium.
- Third, the investigators will assess plasma markers of free radical production.
- Conditions
- Septic Encephalopathy, Delirium, Sepsis
- Being tested
- Delirium and with septic encephalopathy.
- Keywords
- Sepsis, Encephalopathy, Delirium, ICU, EEG, MRI, Cognitive tests
- Medical subject headings
- Sepsis-Associated Encephalopathy, Delirium, Sepsis, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium and with septic encephalopathy.Other
Delirium or septic encephalopathy survivors will be analized in the same way: Cognitive tests, EEG and MRI.
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG frequencies
Automatically measurments of frequencies band
Measured: Through study completion, an average of 1 year
MRI
Structural and diffusion tensor imaging sequences
Measured: Through study completion, an average of 1 year
Cognitive test: Verbal-Paired Associates
Assessing explicit episodic memory performance
Measured: Through study completion, an average of 1 year
Cognitive test: Mini-Mental State Examination (MMSE)
neurocognitive function
Measured: Through study completion, an average of 1 year
Cognitive test: Trail-Making Test and the Symbol-Digit Modalities Test (SDMT),
Speed of processing and executive functioning
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Mar 2019
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Not enough subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Olalla Urdanibia Centelles, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562689
- Sponsor's protocol ID
- 63657
- Status last verified
- Mar 2020
- First submitted
- 8 Jun 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: EEG, cognitive tests and MRI could be available for other researchers in the field.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing in Patients Surviving Delirium. Neuropsychological, EEG and Structural Brain Correlates.
- ClinicalTrials.gov ID
- NCT03562689
- Acronym / sponsor ID
- 63657
- Conditions
- Septic Encephalopathy, Delirium, Sepsis
- Keywords
- Sepsis, Encephalopathy, Delirium, ICU, EEG, MRI, Cognitive tests
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Not enough subjects.
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Jun 2018 (actual)
- 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.
The research program explores how delirium influenced brain function in patients surviving delirium and septic encephalopathy from a non neurological specialized ICU cohort from 2013 to 2015 in Rigshospitalet (Glostrup).
Detailed description
The overall aim is to understand the pathophysiological mechanism in delirium and septic encephalopathy and its consequences.
For this purpose we will:
- Provide extensive cognitive testing. These results provide the basis for categorization of patients surviving septic encephalopathy and delirious patients.
- First, the investigators will examine if the differences in cognitive function is reflected in the ability of the brain to generate high-frequency electrical oscillations that accompany and underlie perception, attention, cognition, memory formation and retrieval. It will be performed by carrying out continuous EEG (cEEG) and by examination of steady-state evoked cognitive EEG responses.
- Second, the investigations will examine MRI, structural and diffusion tensor imaging sequences. Hippocampal, thalamic, amygdala, lentiform nucleus and cingulate cortex volumes will be determined bilaterally and will be compared between individuals with healthy brain aging and patients that survived delirium.
- Third, the investigators will assess plasma markers of free radical production.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors of the critical ill cohort which were included the ones without known acute central nervous system affection admitted to a medical ICU with sepsis or septic shock, mono- or multi organ failure (respiratory insufficiency, circulatory shock, hepatic and/or renal failure) as indicated by a need for invasive or non-invasive mechanical ventilation, vasoactive drugs and/or CRR)
Key inclusion criteria (2 listed)
- Age >18 years;
- Length of stay >24 hours in the ICU.
Key exclusion criteria (3 listed)
- Expected death <24 hours;
- Psychiatric illness; pre-existing delirium; severe dementia; cerebrovascular event <six months; major surgery <two months;
- Non-Danish or English speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delirium and with septic encephalopathy.Delirium or septic encephalopathy survivors will be analized in the same way: Cognitive tests, EEG and MRI. | Other | – |
Primary outcome
EEG frequencies
Time frame: Through study completion, an average of 1 year
Automatically measurments of frequencies band
MRI
Time frame: Through study completion, an average of 1 year
Structural and diffusion tensor imaging sequences
Cognitive test: Verbal-Paired Associates
Time frame: Through study completion, an average of 1 year
Assessing explicit episodic memory performance
Cognitive test: Mini-Mental State Examination (MMSE)
Time frame: Through study completion, an average of 1 year
neurocognitive function
Cognitive test: Trail-Making Test and the Symbol-Digit Modalities Test (SDMT),
Time frame: Through study completion, an average of 1 year
Speed of processing and executive functioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: Undecided. EEG, cognitive tests and MRI could be available for other researchers in the field.
Related trials for Septic Encephalopathy
Not yet recruitingObservational study
EEG Changes and Cognitive Profiles in Sepsis Patients With Different Inflammatory Phenotypes
Sepsis, Sepsis Associated Encephalopathy
Active, not recruitingObservational study
Sepsis Associated Encephalopathy (SAE) Biomarkers
Sepsis, Altered Mental Status
Not yet recruitingPhase 3
Evaluation of Early Administration of Levetiracetam in the Prevention and Treatment Encephalopathy in Septic Shock: Randomized, Double-blind, Placebo-controlled Trial
Septic Shock
RecruitingObservational study
Establishment of a Cohort of Patients With Sepsis-associated Encephalopathy (SAE)
Sepsis-Associated Encephalopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Septic Encephalopathy and Delirium, run by Copenhagen University Hospital, Rigshospitalet 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 2 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: paused, as of the sponsor's last update on 11 Mar 2020. 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?
Results are not available in the source record.
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?
EEG frequencies (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2020.