NCT03098472: CADUCeuS

Cholinesterase Activity and DeliriUm During Critical Illness Study

Completed Last updated 11 March 2022

What this trial tests

trial in Delirium in 279 participants. Completed in 1 February 2021.

Timeline

8 May 2017

Primary endpoint
1 January 2020

1 February 2021

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	279
Start date	8 May 2017
Primary completion	1 January 2020
Estimated completion	1 February 2021
Sites	1 location across United States

Conditions studied

• Delirium — all drugs for Delirium →
• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Delirium or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association between cholinesterase activity and critical illness brain dysfunction.
   Hughes CG, Boncyk CS, Fedeles B, Pandharipande PP, et al · · 2022 · cited 34× · PMID 36474266 · DOI 10.1186/s13054-022-04260-1