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Completed

NCT Number: NCT06555679

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

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.

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Key information

Conditions

Alcohol Withdrawal Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Brest

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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, ...)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PAWSS-ICU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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