Evaluation of a Predictive Score for the Onset of Moderate to Severe Alcohol Withdrawal Syndrome, the PAWSS, in a Population of Intensive Care Patients at Brest University Hospital (PAWSS-ICU)

August 14, 2024 updated by: University Hospital, Brest
alcohol use disorder (AUD) is a very common condition in patients admitting in ICU's. Brutal stop of alcohol consumption may lead to a withdrawal syndrome, wich is associated with a worse outcome for ICU patients (longuer ICU and hospital stays, use of mechanical ventilation, traumas). The aim of this study is to valid a score (PAWSS : prediction of alcohol withdrawal syndrome (AWS) scale) to predict at admission mild to severe AWS in ICU patients population.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • CHRU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

  • more than 18 years old
  • able to answer to PAWSS in the first 48hours of ICU stay

Exclusion Criteria:

  • No alcohol consumption in the last 30 days
  • hospital stay of more than 5 days at ICU admission
  • hospital stay less than 5 days in total
  • expected sedation time of more than 48h
  • patient not able to understand the PAWSS
  • no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of PAWSS statistic performances to predict AWS in ICU patients
Time Frame: the first 5 days of hospital stay
Evaluation of sensitivity, specificity, positive and negative predictive values of PAWSS to predict moderate or severe AWS (defined by a CIWA greater than or equal to 8)
the first 5 days of hospital stay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of a new score, the PAWSS-ICU, able to predict AWS in ICU patients
Time Frame: during ICU stay

To this end, the characteristics of the [no weaning/minimal weaning] and [moderate weaning/severe weaning] groups will be compared, in order to identify significant differences between these two groups, and thus enable the creation of a new score.

On an exploratory basis :

  • assess the incidence of alcohol misuse and withdrawal syndrome in our population,
  • assess the incidence of complications in the population with moderate to severe withdrawal (trauma, occurrence of pneumopathy, need for mechanical ventilation),
  • assess length of hospital stay and in-hospital mortality.

Translated with DeepL.com (free version)
during ICU stay

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of alcohol use disorders (AUD) ans AWS in our population
Time Frame: during ICU stay

AUD definition for our study :

  • AUD is mentionned in patient's medical record
  • heavy alcohol use (more than 3 drinks a day for a men ant more than 2 drinks a day for a woman)
  • harmful use : physical or psychological complications of alcohol use (liver cirrhosis, depression, ...)
during ICU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

June 26, 2023

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC22.0126 PAWSS-ICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Withdrawal Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe