Abuse and Addiction in ICU

NCT ID: NCT02951793

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2022-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AUDIT-C > 4

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

AUDIT-C

Intervention Type: 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.

AUDIT-C <=4

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

AUDIT-C

Intervention Type: 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.

Smoking history positive last year

Who smoke cigarette within 1-year prior to ICU admission

Smoking history

Intervention Type: 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

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

Smoking history

Intervention Type: 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)

Prior psychotropic medication use - yes

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

Prior psychotropic medication use

Intervention Type: 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

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

Prior psychotropic medication use

Intervention Type: 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.

Interventions

AUDIT-C

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.

Intervention Type: OTHER

Smoking history

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)

Intervention Type: OTHER

Prior psychotropic medication use

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.

Intervention Type: OTHER

Other Intervention Names

Alcohol Use Disorders Identification Test

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jinwoo Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinwoo Lee, Professor

Role: STUDY_CHAIR

Seoul National University Hospital

Jungsil Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

addiction742

Identifier Type: -

Identifier Source: org_study_id