Abuse and Addiction in ICU
18. august 2021 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Forventet)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Seoul, Korea, Republikken, 110744
- Seoul National University Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
AUDIT-C > 4
Significant alcohol use within 1 year prior to ICU admission (AUDIT-C>4)
|
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 navn:
|
|
AUDIT-C <=4
No significant alcohol use within 1 year prior to ICU admission (AUDIT-C: equal or less than 4)
|
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 navn:
|
|
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)
|
|
Smoking history negative last year
Who did not 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)
|
|
Prior psychotropic medication use - yes
Who used psychotropic medication within 1-year prior to ICU admission
|
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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Delirium during ICU stay
Tidsramme: From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
|
From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
|
|
|
Mortality
Tidsramme: From date of ICU admission until the date of death, assessed up to 3 months
|
Death in MICU
|
From date of ICU admission until the date of death, assessed up to 3 months
|
|
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
|
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
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
|
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
|
|
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
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Jinwoo Lee, Professor, Seoul National University Hospital
- Hovedetterforsker: Jungsil Lee, M.D., Seoul National University Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2016
Primær fullføring (Forventet)
1. desember 2022
Studiet fullført (Forventet)
1. desember 2022
Datoer for studieregistrering
Først innsendt
11. oktober 2016
Først innsendt som oppfylte QC-kriteriene
30. oktober 2016
Først lagt ut (Anslag)
1. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- addiction742
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .