Substance Withdrawal SyndromeNCT02951793
Abuse and Addiction in ICU
An observational study of Substance Withdrawal Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- AUDIT-C, Smoking history and Prior psychotropic medication use
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria
Who may be able to join
- Patients who are older than 18 years of age
- New patients admitted to medical ICU for the 1st time during their stay in hospital
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- AUDIT-C, Smoking history, Prior psychotropic medication use
- Keywords
- intensive care unit, delirium, substance withdrawal
- Medical subject headings
- Substance Withdrawal Syndrome, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUDIT-COther
Also called Alcohol Use Disorders Identification Test
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.
Smoking historyOther
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 useOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AUDIT-C > 4 | Significant alcohol use within 1 year prior to ICU admission (AUDIT-C>4) Receives: Other: AUDIT-C | |
| AUDIT-C <=4 | No significant alcohol use within 1 year prior to ICU admission (AUDIT-C: equal or less than 4) Receives: Other: AUDIT-C | |
| Smoking history positive last year | Who smoke cigarette within 1-year prior to ICU admission Receives: Other: Smoking history | |
| Smoking history negative last year | Who did not smoke cigarette within 1-year prior to ICU admission Receives: Other: Smoking history | |
| Prior psychotropic medication use - yes | Who used psychotropic medication within 1-year prior to ICU admission Receives: Other: Prior psychotropic medication use | |
| Prior psychotropic medication use - no | Who did not use psychotropic medication within 1-year prior to ICU admission Receives: Other: Prior psychotropic medication use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium during ICU stay
Measured: From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
Secondary outcomes (5)
ICU length of stay
Measured: 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
Death in MICU
Measured: From date of ICU admission until the date of death, assessed up to 3 months
Maximal doses of dexmedetomidine
Measured: 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
Cumulative dose of dexmedetomidine during the patient's MICU stay
Measured: 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
Cumulative dose of midazolam during the patient's MICU stay
Measured: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwoo Lee, Seoul National University Hospital
- Investigators
- Jinwoo Lee, Professor, Study chair, Seoul National University HospitalJungsil Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951793
- Sponsor's protocol ID
- addiction742
- Status last verified
- Aug 2021
- First submitted
- 11 Oct 2016
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recent Alcohol, Smoking and Psychotropic Drug Use on Delirium in ICU
- ClinicalTrials.gov ID
- NCT02951793
- Acronym / sponsor ID
- addiction742
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- intensive care unit, delirium, substance withdrawal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AUDIT-C > 4 | – | Other: AUDIT-CSignificant alcohol use within 1 year prior to ICU admission (AUDIT-C>4) |
| AUDIT-C <=4 | – | Other: AUDIT-CNo significant alcohol use within 1 year prior to ICU admission (AUDIT-C: equal or less than 4) |
| Smoking history positive last year | – | Other: Smoking historyWho smoke cigarette within 1-year prior to ICU admission |
| Smoking history negative last year | – | Other: Smoking historyWho did not smoke cigarette within 1-year prior to ICU admission |
| Prior psychotropic medication use - yes | – | Other: Prior psychotropic medication useWho used psychotropic medication within 1-year prior to ICU admission |
| Prior psychotropic medication use - no | – | Other: Prior psychotropic medication useWho did not use psychotropic medication within 1-year prior to ICU admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For all new ICU admissions above age of 18 years, except for those who fulfill exclusion criteria
Key inclusion criteria (2 listed)
- Patients who are older than 18 years of age
- New patients admitted to medical ICU for the 1st time during their stay in hospital
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUDIT-CAlso: Alcohol Use Disorders Identification TestPatients 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. | Other | AUDIT-C <=4, AUDIT-C > 4 |
| Smoking historyPatients 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) | Other | Smoking history negative last year, Smoking history positive last year |
| Prior psychotropic medication usePatients 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. | Other | Prior psychotropic medication use - no, Prior psychotropic medication use - yes |
Primary outcome
Delirium during ICU stay
Time frame: From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months
5 secondary outcomes
ICU length of stay
Time frame: 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
Time frame: From date of ICU admission until the date of death, assessed up to 3 months
Maximal doses of dexmedetomidine
Time frame: 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
Time frame: 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
Time frame: From date of ICU admission until the date of first documented discharge from ICU or death, whichever came first, assessed up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Substance Withdrawal Syndrome
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
RecruitingPhase 1
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Opioid Use Disorder
Not yet recruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
Invasive Ventilation, Infant Pain
Not yet recruitingPhase 4
Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
E Cigarette Use, Cessation, Tobacco
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinwoo Lee, Professor study chair
Seoul National University Hospital
Jungsil Lee, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Withdrawal Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium during ICU stay (time frame: From date of ICU admission until the date of ICU discharge, whichever came first, assessed up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.