Alcohol Withdrawal SyndromePAWSS-ICUNCT06555679
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
An observational study of Alcohol Withdrawal Syndrome, run by University Hospital, Brest at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alcohol Withdrawal Syndrome
- How many people
- 403 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2022to 26 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- more than 18 years old
- able to answer to PAWSS in the first 48hours of ICU stay
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- prediction, intensive care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start27 Jun 2022
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555679
- Sponsor's protocol ID
- 29BRC22.0126 PAWSS-ICU
- Acronym
- PAWSS-ICU
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30167704
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06555679
- Acronym / sponsor ID
- PAWSS-ICU / 29BRC22.0126 PAWSS-ICU
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- prediction, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (2 listed)
- more than 18 years old
- able to answer to PAWSS in the first 48hours of ICU stay
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Creation of a new score, the PAWSS-ICU, able to predict AWS in ICU patients
Time frame: during ICU stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 30167704Wood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Withdrawal Syndrome, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of PAWSS statistic performances to predict AWS in ICU patients (time frame: the first 5 days of hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06555679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.