Clinical trial NCT02951793: Abuse and Addiction in ICU
Official title: Effect of Recent Alcohol, Smoking and Psychotropic Drug Use on Delirium in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Substance Withdrawal Syndrome
Keywords: intensive care unit
delirium
substance withdrawal
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria

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.


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

Primary outcomes:
measure: Delirium during ICU stay
timeFrame: From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
Secondary outcomes:
measure: ICU length of stay
timeFrame: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
measure: Mortality
timeFrame: From date of ICU admission until the date of death, assessed up to 3 months
measure: Maximal doses of dexmedetomidine
timeFrame: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
measure: Cumulative dose of dexmedetomidine
timeFrame: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
measure: Cumulative dose of midazolam
timeFrame: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jinwoo Lee, Professor
role: STUDY_CHAIR
affiliation: Seoul National University Hospital
name: Jungsil Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: