NCT03565016

Brief Summary

At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
Last Updated

June 21, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

March 30, 2018

Last Update Submit

June 20, 2018

Conditions

Alcohol AbuseAlcoholism

Keywords

Alcohol use disordersagitationintensive care unitrestlessnessalcohol withdrawal syndromealcohol-dependenceheavy drinking

Outcome Measures

Primary Outcomes (1)

  • One-Year Mortality

    Assessment of mortality at one year after ICU discharge

    The primary outcome measure was assessed at one year after ICU discharge

Interventions

no interventional studyOTHER

no interventional study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • All consecutive patients aged 18 years old or more admitted in ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

AlcoholismPsychomotor Agitation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Mickael Vour'ch, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2018

First Posted

June 21, 2018

Study Start

June 11, 2012

Primary Completion

November 25, 2013

Study Completion

November 25, 2013

Last Updated

June 21, 2018

Record last verified: 2018-03

Locations

FR(1)