Abuse and Addiction in ICU
18. august 2021 opdateret af: Jinwoo Lee, Seoul National University Hospital
Effect of Recent Alcohol, Smoking and Psychotropic Drug Use on Delirium in ICU
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken, 110744
- Seoul National University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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AUDIT-C > 4
Significant alcohol use within 1 year prior to ICU admission (AUDIT-C>4)
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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.
Andre navne:
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AUDIT-C <=4
No significant alcohol use within 1 year prior to ICU admission (AUDIT-C: equal or less than 4)
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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.
Andre navne:
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Smoking history positive last year
Who smoke cigarette within 1-year prior to ICU admission
|
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)
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Smoking history negative last year
Who did not smoke cigarette within 1-year prior to ICU admission
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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)
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Prior psychotropic medication use - yes
Who used psychotropic medication within 1-year prior to ICU admission
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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.
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Prior psychotropic medication use - no
Who did not use psychotropic medication within 1-year prior to ICU admission
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Delirium during ICU stay
Tidsramme: From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
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From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ICU length of stay
Tidsramme: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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Mortality
Tidsramme: From date of ICU admission until the date of death, assessed up to 3 months
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Death in MICU
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From date of ICU admission until the date of death, assessed up to 3 months
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Maximal doses of dexmedetomidine
Tidsramme: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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Cumulative dose of dexmedetomidine
Tidsramme: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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Cumulative dose of dexmedetomidine during the patient's MICU stay
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From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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Cumulative dose of midazolam
Tidsramme: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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Cumulative dose of midazolam during the patient's MICU stay
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From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Jinwoo Lee, Professor, Seoul National University Hospital
- Ledende efterforsker: Jungsil Lee, M.D., Seoul National University Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2016
Primær færdiggørelse (Forventet)
1. december 2022
Studieafslutning (Forventet)
1. december 2022
Datoer for studieregistrering
Først indsendt
11. oktober 2016
Først indsendt, der opfyldte QC-kriterier
30. oktober 2016
Først opslået (Skøn)
1. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- addiction742
Plan for individuelle deltagerdata (IPD)
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