Neuronal Damage In Delirium Study

NCT03724201 | Completed DMC

• 1 other identifier: REB18-0409
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 homogeneous population of mechanically ventilated patients with sepsis.

Conditions

Delirium

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Once on the first day of enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients with sepsis will be recruited from the largest adult ICU in Calgary, Alberta Foothills Medical Centre (FMC).

You may qualify if:

• 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

You may not qualify if:

• Neurological injury or neurodegenerative condition

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T3A5E4, Canada

Location

Related Links

• Study description

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be isolated from venous blood samples.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsten M Fiest, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: July 30, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)