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Cholinesterase Activity and DeliriUm During Critical Illness Study

Cholinesterase Activity and Delirium During Critical Illness Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03098472
Acronym
CADUCeuS
Enrollment
279
Registered
2017-03-31
Start date
2017-05-08
Completion date
2021-02-01
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Delirium

Brief summary

Delirium is a syndrome of acute brain dysfunction involving attention and cognition that affects up to half of older hospitalized patients and 50%-75% of critically ill ICU patients, such that millions of patients worldwide experience this acute threat to their health and well being every year. One-third to half of critical illness survivors struggle with a dementia-like disorder similar in severity to moderate-to-severe traumatic brain injury or Alzheimer's Disease, and the only proven risk factor that is potentially modifiable is delirium in the ICU. Despite the frequency and impact of delirium in the ICU, little is known regarding the biological mechanisms that lead to this form of organ dysfunction during critical illness. A widely held hypothesis proposes that inflammation is regulated by the cholinergic system, and that this interaction plays a pivotal role whether delirium developments in the setting of acute illness. Acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) are enzymes that hydrolyze the neurotransmitter acetylcholine. Changes in the activity of these enzymes, which can be measured in whole blood, reflect altered regulation of circulating acetylcholine. AChE and BuChE activities have promise as both predictors of delirium (when found to be low at admission) and biomarkers of delirium (when low during serial measurement). Neither of these biomarkers, however, have been studied in the ICU setting where delirium risk is the highest. The current investigation, therefore will be the first to determine the validity of circulating AChE and BuChE activities as biomarkers of delirium during critical illness and subsequent cognitive impairment after discharge. This study will measure whole blood AChE and butyrylcholinesterase BuChE activities within the framework of the ICU Delirium and Cognitive Impairment Study Group's ongoing clinical trials in critically ill patients.

Interventions

None listed

Sponsors

DR. FRANZ KOHLER CHEMIE GMBH
CollaboratorUNKNOWN
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* English-speaking adults (\>18 years of age) treated for acute respiratory failure (with mechanical ventilation or non-invasive positive pressure ventilation \[NIPPV\]) and/or shock (with vasopressors) in a medical and/or surgical ICU at Vanderbilt University Medical Center enrolled in an ICU Delirium and Cognitive Impairment Study Group's clinical trials.

Exclusion criteria

for the parent studies are summarized below. No additional

Design outcomes

Primary

MeasureTime frameDescription
DeliriumDuring hospital stay until death or hospital discharge, whichever comes first, up to 30 daysConfusion Assessment Method for the ICU

Secondary

MeasureTime frameDescription
Global cognitionAt 3, 6, and/or 12 months after hospital discharge up to 18 months after dischargeNeuropsychological battery

Other

MeasureTime frameDescription
Activities of daily livingAt 3, 6, and/or 12 months after hospital discharge up to 18 months after dischargeKatz Index of Independence in Activities of Daily Living
Instrumental activities of daily livingAt 3, 6, and/or 12 months after hospital discharge up to 18 months after dischargeFunctional activities questionnaire
Quality of life and generic health statusAt 3, 6, and/or 12 months after hospital discharge up to 18 months after dischargeEQ-5D
ComaDuring hospital stay until death or hospital discharge, whichever comes first, up to 30 daysRichmond Agitation Sedation Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026