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Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04872010
Collaborator
(none)
4,000
Enrollment
16
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort
    Anticipated Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Sepsis organ function status and survival analysis. [2022.09.30]

      Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis;

    2. It is estimated that the patient's ICU stay ≥24 hours;

    3. Obtain informed consent and sign an informed consent form.

    Exclusion Criteria:

    1. The patient's ICU hospital stay is less than 24 hours;

    2. Participated in other clinical research;

    3. Failed to sign the informed consent form.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shuming Pan, Deputy Dean of Xinhua Hospital, Leader of Emergency Medicine Science Department, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04872010
    Other Study ID Numbers:
    • SHDC2020CR6030
    First Posted:
    May 4, 2021
    Last Update Posted:
    May 4, 2021
    Last Verified:
    Apr 1, 2021
    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:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of May 4, 2021