Alcohol AbuseNCT03565016
Consequences of At-risk Alcohol Consumption in ICU Patients
An observational study of Alcohol Abuse and Alcoholism, run by Nantes University Hospital at 1 site in France.
Trial summary
At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcoholism
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2012to 25 Nov 2013
- 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: patients aged 18 years old or more admitted in ICU non-at-risk drinkers or at-risk drinkers according to the National Institute of Alcohol Abuse and Alcoholism criteria
Who may be able to join
- All consecutive patients aged 18 years old or more admitted in ICU
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of At-risk Alcohol Consumption in ICU Patients : the Impact OH Study.
At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.
Read the detailed description
Alcohol-use disorder has a significant impact on morbidity in surgical intensive care units and is known to cause alcohol withdrawal syndrome which mortality can reach 50% if left untreated. The aim of the study was to assess the impact of alcohol use disorder on one-year mortality and adverse ICU outcomes such as agitation in a Medical Intensive Care Unit.
- Conditions
- Alcohol Abuse, Alcoholism
- Being tested
- no interventional study
- Keywords
- Alcohol use disorders, agitation, intensive care unit, restlessness, alcohol withdrawal syndrome, alcohol-dependence, heavy drinking
- Medical subject headings
- Alcoholism, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventional studyOther
no interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
One-Year Mortality
Assessment of mortality at one year after ICU discharge
Measured: The primary outcome measure was assessed at one year after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start11 Jun 2012
- Primary completion25 Nov 2013
- Study completion25 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Nantes 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickael Vour'ch, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565016
- Sponsor's protocol ID
- Impact OH
- Status last verified
- Mar 2018
- First submitted
- 30 Mar 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of At-risk Alcohol Consumption in ICU Patients : the Impact OH Study.
- ClinicalTrials.gov ID
- NCT03565016
- Acronym / sponsor ID
- Impact OH
- Conditions
- Alcohol Abuse, Alcoholism
- Keywords
- Alcohol use disorders, agitation, intensive care unit, restlessness, alcohol withdrawal syndrome, alcohol-dependence, heavy drinking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2012 (actual)
- Primary completion
- 25 Nov 2013 (actual)
- Study completion
- 25 Nov 2013 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.
Detailed description
Alcohol-use disorder has a significant impact on morbidity in surgical intensive care units and is known to cause alcohol withdrawal syndrome which mortality can reach 50% if left untreated. The aim of the study was to assess the impact of alcohol use disorder on one-year mortality and adverse ICU outcomes such as agitation in a Medical Intensive Care Unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 18 years old or more admitted in ICU non-at-risk drinkers or at-risk drinkers according to the National Institute of Alcohol Abuse and Alcoholism criteria
Key inclusion criteria (1 listed)
- All consecutive patients aged 18 years old or more admitted in ICU
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| no interventional studyno interventional study | Other | – |
Primary outcome
One-Year Mortality
Time frame: The primary outcome measure was assessed at one year after ICU discharge
Assessment of mortality at one year after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
Mickael Vour'ch, Dr principal investigator
Nantes 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 Alcohol Abuse and Alcoholism, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jun 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
One-Year Mortality (time frame: The primary outcome measure was assessed at one year after ICU discharge). 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 21 Jun 2018.