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Expression of TIM-3 on Lymphocytes in Sepsis

Sponsor
Changhai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02319876
Collaborator
(none)
80
Enrollment
1
Location
21.9
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Immunosuppression is the leading cause of death in septic patients.Lymphocyte apoptosis has been recognized as an important step in the pathogenesis of sepsis. Previous studies indicated that T cell immunoglobulin and mucin protein 3 (TIM-3) is a type I cell surface protein and was identified as a marker of lymphocyte dysfunction. The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its further role in immunosuppression during sepsis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Expression and the Clinical Significance of TIM-3 on Lymphocytes During Sepsis
    Study Start Date :
    Feb 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Severe sepsis

    Patients with severe sepsis
    SIRS patient

    Patients after elective surgeries presented with SIRS but without sepsis
    Volunteer

    Volunteers

    Outcome Measures

    Primary Outcome Measures

    1. TIM-3 expression on CD4+, CD8+ T cells and CD14+ monocytes [within 24h after recruitment]

      TIM-3 level on T cells was compared between different populations.

    Secondary Outcome Measures

    1. 28-day mortality [28 days after diagnosis of sepsis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patients with severe sepsis

    • patients undergo invasive spine surgery

    • healthy volunteers

    Exclusion Criteria:

    • patients with immunodeficient diseases

    • patients who accept glucocorticoid or immunosuppressant

    • patients with an age older than 18 years

    • patients providing the informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology and Intensive Care, Changhai Hospital Shanghai Shanghai China 200433

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    • Principal Investigator: Xiaoming Deng, M.D., Ph.D., Changhai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaoming Deng, professor and chief, Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT02319876
    Other Study ID Numbers:
    • TIM3-SEPSIS
    • 81201492
    First Posted:
    Dec 18, 2014
    Last Update Posted:
    Jul 29, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Jul 29, 2015