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Neuronal Damage In Delirium Study

NCT ID: NCT03724201

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-30

Study Completion Date

2019-05-01

Brief Summary

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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

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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

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Delirium

Keywords

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Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Neurocognitive Disorders Mental Disorders Biomarkers Pathophysiology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

Neurological injury or neurodegenerative condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Kirsten Fiest

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kirsten M Fiest, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Related Links

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http://cumming.ucalgary.ca/labs/calgary-critical-care-research-network/research/ongoing-projects/ndid-summary

Study description

Other Identifiers

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REB18-0409

Identifier Type: -

Identifier Source: org_study_id