Abuse and Addiction in ICU

NCT02951793 | Unknown DMC

• 1 other identifier: addiction742
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are seeking to determine the impact of recent alcohol, smoking or psychotropic drug use prior to intensive care unit (ICU) admission on incidence of delirium and sedation requirements. Study design: A prospective observational study, in a medical ICU of a tertiary university hospital. Methods: For all new ICU admissions, a 1-page questionnaire including Alcohol Use Disorders Identification Test (AUDIT-C), smoking history and prior medication use was given to the patient or closest family members. Delirium was assessed by trained ICU nurses using Intensive Care Delirium Screening Checklist and Richmond Agitation-Sedation Scale.

Conditions

Substance Withdrawal Syndrome

Keywords

intensive care unit; delirium; substance withdrawal

Outcome Measures

Primary Outcomes (1)

• Delirium during ICU stay

  From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months

Secondary Outcomes (5)

• ICU length of stay

  From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months

• Mortality

  From date of ICU admission until the date of death, assessed up to 3 months

• Maximal doses of dexmedetomidine

  From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months

• Cumulative dose of dexmedetomidine

  From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months

• Cumulative dose of midazolam

  From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months

Study Arms (6)

AUDIT-C > 4

Significant alcohol use within 1 year prior to ICU admission (AUDIT-C\>4)

Other: AUDIT-C

AUDIT-C <=4

No significant alcohol use within 1 year prior to ICU admission (AUDIT-C: equal or less than 4)

Other: AUDIT-C

Smoking history positive last year

Who smoke cigarette within 1-year prior to ICU admission

Other: Smoking history

Smoking history negative last year

Who did not smoke cigarette within 1-year prior to ICU admission

Other: Smoking history

Prior psychotropic medication use - yes

Who used psychotropic medication within 1-year prior to ICU admission

Other: Prior psychotropic medication use

Prior psychotropic medication use - no

Who did not use psychotropic medication within 1-year prior to ICU admission

Other: Prior psychotropic medication use

Interventions

AUDIT-C OTHER

Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including AUDIT-C about his/her alcohol behavior during last year and will be categorized into two groups: Those with AUDIT-C\>4 versus AUDIT-C of 4 or below.

Also known as: Alcohol Use Disorders Identification Test

AUDIT-C <=4; AUDIT-C > 4

Smoking history OTHER

Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including smoking history during last year and will be categorized into two groups: Current smoker versus ex- or never smoker (we also recorded smoking pack-years to distinguish heavy smokers)

Smoking history negative last year; Smoking history positive last year

Prior psychotropic medication use OTHER

Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including psychotropic medication use prior admission to ICU and will be categorized into two groups: Those who use psychotropic medication versus those who do not use psychotropic medication.

Prior psychotropic medication use - no; Prior psychotropic medication use - yes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria

You may qualify if:

• Patients who are older than 18 years of age
• New patients admitted to medical ICU for the 1st time during their stay in hospital

You may not qualify if:

• Had history of stroke or other primary neurologic disease
• GCS ≤ 8 prior to ICU admission
• Transferred from other ICU (except for emergency ICU stay which is limited to less than 36 hours)
• Not registered within 24 hours after admission
• Refused to participate
• If comatous state persists
• Delirium assessment is not possible due to newly developed neurologic disease, such as cerebral infarction
• Medical ICU stay less than 24 hours
• Readmission to medical ICU

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Delirium

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jinwoo Lee, Professor

  Seoul National University Hospital

  STUDY CHAIR

• Jungsil Lee, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: November 1, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)