Abuse and Addiction in ICU

• Conditions: Substance Withdrawal Syndrome

• Registration Number: NCT02951793
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-30
• Study First Posted: 2016-11-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-20
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium during ICU stay	From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months

Secondary Outcome Measures

Name	Time	Method
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
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 dexmedetomidine during the patient's MICU stay
Mortality	From date of ICU admission until the date of death, assessed up to 3 months	Death in MICU
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	Cumulative dose of midazolam during the patient's MICU stay

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of