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Vit B12: Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients

Sponsor
University of Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT04008446
Collaborator
(none)
100
Enrollment
1
Location
43
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result.

The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients : an Observational Study.
    Actual Study Start Date :
    Jun 1, 2019
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Holotranscobalamin (HTC) levels [6 days]

      HTC levels in patients with infection and sepsis compared to patients with infection without sepsis.

    Secondary Outcome Measures

    1. Vitamin B12 levels [6 days]

      Levels of vitamin B12 in patients with infection and sepsis compared to patients with infection without sepsis

    2. Methylmalonic acid (MMA) levels [6 days]

      Levels of ethylmalonic acid (MMA) in patients with infection and sepsis compared to patients with infection without sepsis

    Eligibility Criteria

    Criteria

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

    • Adults (≥18 years old)

    • Infection, confirmed by a positive culture result

    • Signed informed consent.

    Exclusion Criteria:

    • Pregnancy and/or breast feeding

    • Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Zurich Zurich Switzerland 8091

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT04008446
    Other Study ID Numbers:
    • 2019-00702
    First Posted:
    Jul 5, 2019
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bacteremia

    Study Results

    No Results Posted as of Mar 14, 2022