DeliriumNDIDNCT03724201
Neuronal Damage In Delirium Study
An observational study of Delirium, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate associations between neuronal damage biomarkers (S100 calcium-binding protein beta [S-100β], neuron-specific enolase [NSE], ubiquitin carboxy-terminal hydrolase L1 [UCHL1], and brain-derived neurotropic factor [BDNF]) and delirium severity and subsyndromal delirium in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2018to 1 May 2019
- 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: Mechanically ventilated patients with sepsis will be recruited from the largest adult ICU in Calgary, Alberta Foothills Medical Centre (FMC).
Who may be able to join
- Located in FMC ICU
- Able to consent or have a surrogate decision-maker able to consent
- Richmond Agitation and Sedation Scale Score ≥ -3
- Glasgow Coma Scale (GCS) score ≥ 9
- Able to communicate with the study team (English language, no hearing impairments)
- Expected to remain in the ICU longer than 24 hours
- Sequential Organ Failure Assessment (SOFA) score ≥2 (indicates sepsis based off of Sepsis 3 Guidelines)
- Invasively mechanically ventilated
Who cannot join
- Neurological injury or neurodegenerative condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delirium Severity, Subsyndromal Delirium, and Inflammation-associated Biomarkers in Mechanically Ventilated Patients With Sepsis
The purpose of this study is to evaluate associations between neuronal damage biomarkers (S100 calcium-binding protein beta [S-100β], neuron-specific enolase [NSE], ubiquitin carboxy-terminal hydrolase L1 [UCHL1], and brain-derived neurotropic factor [BDNF]) and delirium severity and subsyndromal delirium in a homogeneous population of mechanically ventilated patients with sepsis.
Read the detailed description
Due to high levels of inflammation, patients with sepsis are especially at risk of developing delirium, an organic state of confusion that affects over 80% of mechanically ventilated patients during their intensive care stay. A growing body of literature suggests that the severity of delirium symptoms may also have a significant impact on negative outcomes associated with delirium, including mortality, length of hospital stay, duration of mechanical ventilation, and functional and cognitive impairment. Similarly, recent literature suggests that patient outcomes may be worsened by a subthreshold severity level of delirium, known as subsyndromal delirium. Despite the urgent need to understand delirium and subsyndromal delirium etiology for better detection and management strategies, the multifactorial pathophysiology of delirium is still largely unknown. Clinical biomarker studies evaluating levels of S100 calcium-binding protein beta (S-100β), neuron-specific enolase (NSE), ubiquitin carboxy-terminal hydrolase L1 (UCHL1), and brain-derived neurotropic factor (BDNF) have suggested evidence for their role in delirium pathophysiology, but significant associations with delirium severity and subsyndromal delirium have not been reliably established. Evaluating the dose-response relationship of S-100β, NSE, UCHL1, and BDNF with delirium severity and subsyndromal delirium in a homogeneous population of mechanically ventilated patients with sepsis will provide novel insight on the etiological pathway of delirium. The investigators will evaluate effect modification and confounding by inflammation and blood-brain barrier permeability by measuring well-established biomarkers, interleukin-6 (IL-6) and E-selectin, respectively. Understanding the role of neuronal damage in delirium may be a promising avenue to develop better screening practices and neuroprotective management strategies that may reduce long-term cognitive and functional deficits associated with delirium.
- Conditions
- Delirium
- Keywords
- Delirium, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders, Biomarkers, Pathophysiology
- Medical subject headings
- Delirium, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium severity and subsyndromal delirium
The Confusion Assessment Method for the Intensive Care Unit 7 (CAM-ICU-7) will be completed once per day by a trained research assistant. The CAM-ICU-7 evaluates features and severity of delirium, including 1) acute onset or fluctuating course; 2) inattention; 3) disorganized thinking; and 4) altered level of consciousness. Features 1 and 2, and 3 or 4 must be present to indicate delirium. A non-zero score that does not meet the criteria of delirium indicates subsyndromal delirium. Feature 1 is scored dichotomous (0 or 1), while features 2, 3, and 4 are scored ranging between 0 and 2 (minimum 0, maximum 7). Higher scores indicate more severe delirium or subsyndromal delirium on delirium- or subsyndromal delirium-positive assessments.
Measured: Up to five days
Serum concentrations of serum S-100β, NSE, UCHL1, BDNF, E-selectin, and IL-6
A serum sample will be collected and processed for batched analysis on the first day of participant enrollment. Serum concentrations of target biomarkers will be quantified using Addressable Laser Bead Immunoassay (ALBIA), a high throughput immunosorbent assay that measures emissions from fluorescently labelled microbeads complexed with antigen-specific capture antibodies to yield a continuous measure of analyte concentration.
Measured: Once on the first day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start30 Jul 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Fiest, University of Calgary
- Investigators
- Kirsten M Fiest, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724201
- Sponsor's protocol ID
- REB18-0409
- Acronym
- NDID
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2018
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Severity, Subsyndromal Delirium, and Inflammation-associated Biomarkers in Mechanically Ventilated Patients With Sepsis
- ClinicalTrials.gov ID
- NCT03724201
- Acronym / sponsor ID
- NDID / REB18-0409
- Conditions
- Delirium
- Keywords
- Delirium, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 30 Oct 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 purpose of this study is to evaluate associations between neuronal damage biomarkers (S100 calcium-binding protein beta [S-100β], neuron-specific enolase [NSE], ubiquitin carboxy-terminal hydrolase L1 [UCHL1], and brain-derived neurotropic factor [BDNF]) and delirium severity and subsyndromal delirium in a homogeneous population of mechanically ventilated patients with sepsis.
Detailed description
Due to high levels of inflammation, patients with sepsis are especially at risk of developing delirium, an organic state of confusion that affects over 80% of mechanically ventilated patients during their intensive care stay. A growing body of literature suggests that the severity of delirium symptoms may also have a significant impact on negative outcomes associated with delirium, including mortality, length of hospital stay, duration of mechanical ventilation, and functional and cognitive impairment. Similarly, recent literature suggests that patient outcomes may be worsened by a subthreshold severity level of delirium, known as subsyndromal delirium. Despite the urgent need to understand delirium and subsyndromal delirium etiology for better detection and management strategies, the multifactorial pathophysiology of delirium is still largely unknown. Clinical biomarker studies evaluating levels of S100 calcium-binding protein beta (S-100β), neuron-specific enolase (NSE), ubiquitin carboxy-terminal hydrolase L1 (UCHL1), and brain-derived neurotropic factor (BDNF) have suggested evidence for their role in delirium pathophysiology, but significant associations with delirium severity and subsyndromal delirium have not been reliably established. Evaluating the dose-response relationship of S-100β, NSE, UCHL1, and BDNF with delirium severity and subsyndromal delirium in a homogeneous population of mechanically ventilated patients with sepsis will provide novel insight on the etiological pathway of delirium. The investigators will evaluate effect modification and confounding by inflammation and blood-brain barrier permeability by measuring well-established biomarkers, interleukin-6 (IL-6) and E-selectin, respectively. Understanding the role of neuronal damage in delirium may be a promising avenue to develop better screening practices and neuroprotective management strategies that may reduce long-term cognitive and functional deficits associated with delirium.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients with sepsis will be recruited from the largest adult ICU in Calgary, Alberta Foothills Medical Centre (FMC).
Key inclusion criteria (8 listed)
- Located in FMC ICU
- Able to consent or have a surrogate decision-maker able to consent
- Richmond Agitation and Sedation Scale Score ≥ -3
- Glasgow Coma Scale (GCS) score ≥ 9
- Able to communicate with the study team (English language, no hearing impairments)
Key exclusion criteria (1 listed)
- Neurological injury or neurodegenerative condition
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
Delirium severity and subsyndromal delirium
Time frame: Up to five days
The Confusion Assessment Method for the Intensive Care Unit 7 (CAM-ICU-7) will be completed once per day by a trained research assistant. The CAM-ICU-7 evaluates features and severity of delirium, including 1) acute onset or fluctuating course; 2) inattention; 3) disorganized thinking; and 4) altered level of consciousness. Features 1 and 2, and 3 or 4 must be present to indicate delirium. A non-zero score that does not meet the criteria of delirium indicates subsyndromal delirium. Feature 1 is scored dichotomous (0 or 1), while features 2, 3, and 4 are scored ranging between 0 and 2 (minimum 0, maximum 7). Higher scores indicate more severe delirium or subsyndromal delirium on delirium- or subsyndromal delirium-positive assessments.
Serum concentrations of serum S-100β, NSE, UCHL1, BDNF, E-selectin, and IL-6
Time frame: Once on the first day of enrollment
A serum sample will be collected and processed for batched analysis on the first day of participant enrollment. Serum concentrations of target biomarkers will be quantified using Addressable Laser Bead Immunoassay (ALBIA), a high throughput immunosorbent assay that measures emissions from fluorescently labelled microbeads complexed with antigen-specific capture antibodies to yield a continuous measure of analyte concentration.
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 20 Dec 2023.
- Individual participant dataSharing planned: No
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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 M Fiest, PhD principal investigator
University of Calgary
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 University of Calgary at 1 site in Canada.
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 8 inclusion and 1 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 20 Dec 2023. 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 Canada. 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?
Delirium severity and subsyndromal delirium (time frame: Up to five days). The study lists 2 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 20 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.