Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098472
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
DR. FRANZ KOHLER CHEMIE GMBH
Information provided by (Responsible Party):
Christopher Hughes, Vanderbilt University Medical Center

Tracking Information
First Submitted Date March 22, 2017
First Posted Date March 31, 2017
Last Update Posted Date February 6, 2020
Actual Study Start Date May 8, 2017
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2017)
Delirium [ Time Frame: During hospital stay until death or hospital discharge, whichever comes first, up to 30 days ]
Confusion Assessment Method for the ICU
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2017)
Global cognition [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
Neuropsychological battery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 19, 2019)
  • 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
  • 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
  • Quality of life and generic health status [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
    EQ-5D
  • Coma [ Time Frame: During hospital stay until death or hospital discharge, whichever comes first, up to 30 days ]
    Richmond Agitation Sedation Scale
Original Other Pre-specified Outcome Measures
 (submitted: March 27, 2017)
  • 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
  • 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
  • Quality of life [ Time Frame: At 3, 6, and/or 12 months after hospital discharge up to 18 months after discharge ]
    EQ-5D
  • Coma [ Time Frame: During hospital stay until death or hospital discharge, whichever comes first, up to 30 days ]
    Richmond Agitation Sedation Scale
 
Descriptive Information
Brief Title Cholinesterase Activity and DeliriUm During Critical Illness Study
Official Title Cholinesterase Activity and Delirium During Critical Illness Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Delirium
  • Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 19, 2019)
279
Original Estimated Enrollment
 (submitted: March 27, 2017)
240
Estimated Study Completion Date January 1, 2021
Actual Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03098472
Other Study ID Numbers CADUCeuS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Christopher Hughes, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators DR. FRANZ KOHLER CHEMIE GMBH
Investigators Not Provided
PRS Account Vanderbilt University Medical Center
Verification Date February 2020