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Effect of Immunophenotype on Prognosis of Sepsis

Sponsor
Southeast University, China (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05602584
Collaborator
(none)
200
Enrollment
1
Location
26
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The popuse of this study is to assess the inflammatory immunophenotypes of sepsis patients are significantly correlated with prognosis, which may provide theoretical basis for precise immune regulation of sepsis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The clinical characteristics and inflammatory/immune markers of sepsis patients were analyzed dynamically and followed up to one year after diagnosis. Through latent category analysis, cluster analysis and other inflammatory immunophenotypes, the clinical characteristics of different inflammatory immunophenotypes and their relationship with the long-term prognosis of sepsis were clarified.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Immunophenotype on Prognosis of Sepsis
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. survival or death in 28 days [From date of randomization until the date of out of ICU or date of death from any cause, whichever came first, assessed up to 28 days]

      observe wether the patients is survival or death in 28 days

    Eligibility Criteria

    Criteria

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

    Inclusion Criteria:Patients with sepsis 3 diagnostic criteria were admitted to ICU; Aged 18 or above; Within 24 hours of diagnosis.

    -

    Exclusion Criteria:Malignant tumor; Autoimmune diseases; Diseases of the blood system; HIV infection; History of high-dose glucocorticoid use (hydrocortisone 200mg/d or other hormone with equivalent titer, more than one week); pregnancy

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Critical Care , Zhong-da Hospital Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Southeast University, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianfeng Xie, Clinical Professor, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT05602584
    Other Study ID Numbers:
    • EOIPOPOS
    First Posted:
    Nov 2, 2022
    Last Update Posted:
    Nov 2, 2022
    Last Verified:
    Oct 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
    Keywords provided by Jianfeng Xie, Clinical Professor, Southeast University, China
    Immunophenotype
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Systemic Inflammatory Response Syndrome

    Study Results

    No Results Posted as of Nov 2, 2022