Abuse and Addiction in ICU
18 de agosto de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Anticipado)
200
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Seoul, Corea, república de, 110744
- Seoul National University Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
Otros nombres:
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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.
Otros nombres:
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Smoking history positive last year
Who 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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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Delirium during ICU stay
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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ICU length of stay
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Jinwoo Lee, Professor, Seoul National University Hospital
- Investigador principal: Jungsil Lee, M.D., Seoul National University Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2016
Finalización primaria (Anticipado)
1 de diciembre de 2022
Finalización del estudio (Anticipado)
1 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
11 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
30 de octubre de 2016
Publicado por primera vez (Estimar)
1 de noviembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- addiction742
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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