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PETHOXICO: Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04557631
Collaborator
(none)
30
Enrollment
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:

  • to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.

  • Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of patients with a Peth concentration greater than 200 µg/L [at the end of study (at 6 months)]

    Secondary Outcome Measures

    1. the concentration of Peth in blood in ambiant temperature [between T0 and 96h and the end of study (at 6 months)]

      descrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and stored at room temperature,

    2. the concentration of Peth in blood at 4°C [between T0 and 96h and the end of study (at 6 months)]

      ecrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and at 4°C.

    3. the concentration of Peth in blood in DBS [between T0 and 4 weeks and the end of study (at 6 months)]

      decrease expressed as a percentage of the initial concentration, in the Dried Blood Spot (DBS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria

    • Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.

    Exclusion Criteria:

    • Patient opposing the use of their personal data in the study

    • Patient subject to protective measures (guardianship or curatorship)

    • Person deprived of liberty

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Olivier COTTENCIN, MD,PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04557631
    Other Study ID Numbers:
    • 2019_02
    • 2019-A02683-54
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Apr 23, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alcoholism

    Study Results

    No Results Posted as of Apr 23, 2021