- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02951793
Abuse and Addiction in ICU
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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Seoul, 대한민국, 110744
- Seoul National University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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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.
다른 이름들:
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Delirium during ICU stay
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ICU length of stay
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Jinwoo Lee, Professor, Seoul National University Hospital
- 수석 연구원: Jungsil Lee, M.D., Seoul National University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- addiction742
개별 참가자 데이터(IPD) 계획
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