NCT06555679

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

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 27, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

August 8, 2024

Last Update Submit

August 14, 2024

Conditions

Keywords

predictionintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Evaluation of PAWSS statistic performances to predict AWS in ICU patients

    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 Outcomes (1)

  • Creation of a new score, the PAWSS-ICU, able to predict AWS in ICU patients

    during ICU stay

Other Outcomes (1)

  • Evaluation of alcohol use disorders (AUD) ans AWS in our population

    during ICU stay

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

Related Publications (1)

  • Wood E, Albarqouni L, Tkachuk S, Green CJ, Ahamad K, Nolan S, McLean M, Klimas J. Will This Hospitalized Patient Develop Severe Alcohol Withdrawal Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2018 Aug 28;320(8):825-833. doi: 10.1001/jama.2018.10574.

    PMID: 30167704BACKGROUND

Study Design

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

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 15, 2024

Study Start

June 27, 2022

Primary Completion

June 26, 2023

Study Completion

June 26, 2023

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations