ClinicalTrials.gov
ClinicalTrials.gov Menu

Cholinesterase Activity and DeliriUm During Critical Illness Study (CADUCeuS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03098472
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
DR. FRANZ KOHLER CHEMIE GMBH
Information provided by (Responsible Party):
Christopher Hughes, Vanderbilt University Medical Center

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.

Condition or disease
Delirium Cognitive Impairment

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cholinesterase Activity and Delirium During Critical Illness Study
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Delirium [ Time Frame: During hospital stay until death or hospital discharge, whichever comes first, up to 30 days ]
    Confusion Assessment Method for the ICU


Secondary Outcome Measures :
  1. Global cognition [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
    Neuropsychological battery


Other Outcome Measures:
  1. Activities of daily living [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
    Katz Index of Independence in Activities of Daily Living

  2. Instrumental activities of daily living [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
    Functional activities questionnaire

  3. Quality of life [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
    EQ-5D

  4. Coma [ Time Frame: During hospital stay until death or hospital discharge, whichever comes first, up to 30 days ]
    Richmond Agitation Sedation Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include all patients in the ICU Delirium and Cognitive Impairment Study Group's ongoing clinical trials over a two-year period of time.
Criteria

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 exclusion criteria are required for this investigation.

Exclusion Criteria:

  • Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
  • Active substance abuse, psychotic disorder, or homelessness without a secondary contact person (which would make long-term follow-up difficult)
  • Blindness or deafness (which would prevent assessment of the study's outcomes)
  • Inability to obtain informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098472


Contacts
Contact: Christopher Hughes, MD 6153435860 christopher.hughes@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Brandi Ricciardone    615-343-7481    brandi.j.ricciardone@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
DR. FRANZ KOHLER CHEMIE GMBH

Responsible Party: Christopher Hughes, Associate Professor of Anesthesiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03098472     History of Changes
Other Study ID Numbers: CADUCeuS
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Nervous System Diseases
Disease Attributes
Cognitive Dysfunction
Delirium
Critical Illness
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes