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NCT03098472 · ClinicalTrials.gov registry record
Cholinesterase Activity and DeliriUm During Critical Illness Study
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 279
- Enrollment target
NCT03098472: Completed study, sponsored by Vanderbilt University Medical Center.
NCT03098472 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 279 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03098472 has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 279 participants
- Enrollment target
Study 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.
Primary Outcome
Confusion Assessment Method for the ICU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2021-02-01 |
What the finished NCT03098472 record still lists
NCT03098472 is an observational study that tracks outcomes without assigning an intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03098472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03098472 about?
NCT03098472 is a clinical study titled "Cholinesterase Activity and DeliriUm During Critical Illness Study". 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-...
What is the current status of trial NCT03098472?
This trial is currently completed. The enrollment target is 279 participants. The study started on 2017-05-08. Estimated completion is 2021-02-01.
Who is sponsoring clinical trial NCT03098472?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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