Abuse and Addiction in ICU

Substance Withdrawal Syndrome Clinical Trial

Official title:

Effect of Recent Alcohol, Smoking and Psychotropic Drug Use on Delirium in ICU

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02951793
• Other study ID #: addiction742
• Status: Active, not recruiting
• Start date: March 2016
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome

Intervention

Other:
• 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.
• 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)
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium during ICU stay		From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
Secondary	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
Secondary	Mortality	Death in MICU	From date of ICU admission until the date of death, assessed up to 3 months
Secondary	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
Secondary	Cumulative dose of dexmedetomidine	Cumulative dose of dexmedetomidine during the patient's MICU 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
Secondary	Cumulative dose of midazolam	Cumulative dose of midazolam during the patient's MICU 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