Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis

Sponsor
Zhongnan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05640037
Collaborator
(none)
120
1
14.2
8.4

Study Details

Study Description

Brief Summary

This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included.

    There are three groups of patients in this study: control group, sepsis group and septic shock group.

    The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6.

    Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis
    Actual Study Start Date :
    Mar 23, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    May 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 28-day all-cause mortality [28 day]

      Number of patients who were confirmed to be dead within 28-day from enrollment onto the study

    Secondary Outcome Measures

    1. ICU all-cause mortality [28 day]

      Number of patients who were confirmed to be dead in ICU from enrollment onto the study

    2. ICU length of stay [28 day]

      Length of intensive care unit stay

    3. Hospital length of stay [28day]

      Length of hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age 18 years or older

    2. Expected length of stay>24 hours in intensive care unit (ICU)

    3. Sequential organ failure assessment (SOFA) score ≥ 2 on ICU admission with a suspicion of infection

    Exclusion Criteria:
    1. anuria

    2. ICU readmission in 28 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongnan Hospital of Wuhan University Wuhan Hubei China

    Sponsors and Collaborators

    • Zhongnan Hospital

    Investigators

    • Study Chair: Dawei Wang, MD, Wuhan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongnan Hospital
    ClinicalTrials.gov Identifier:
    NCT05640037
    Other Study ID Numbers:
    • Dawei Wang
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 12, 2022
    Last Verified:
    Nov 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 Zhongnan Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 12, 2022