Consequences of At-risk Alcohol Consumption in ICU Patients | NCT03565016

Studies
Consequences of At-risk Alcohol Consumption in ICU Patients

NCT03565016

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jun 21, 2018Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Alcohol Abuse
Alcoholism

Interventions

no interventional study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2012Actual

Primary Completion Date

Nov 25, 2013Actual

Completion Date

Nov 25, 2013Actual

First Submitted Date

Mar 30, 2018

First Submission Date that Met QC Criteria

Jun 20, 2018

First Posted Date

Jun 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2018

Last Update Posted Date

Jun 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
no interventional study	Other	no interventional study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One-Year Mortality	Assessment of mortality at one year after ICU discharge	The primary outcome measure was assessed at one year after ICU discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mickael Vour'ch, Dr	Nantes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes		44093	France

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism
D011595	Psychomotor Agitation

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided