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Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04525677
Collaborator
(none)
60
Enrollment
1
Location
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the diagnosis and treatment of patients with sepsis, through routine stool testing and dynamic testing of coagulation function, we found that patients often have stools that are not formed, the proportion of main fecal bacteria is imbalanced, the level of blood bacterial toxins rises, and the abnormal coagulation status indicate the gut microbiome dysbiosis may play an important regulatory role in abnormal blood coagulation in patients with sepsis. Therefore, we propose that the gut microbiome dysbiosis is involved in sepsis-induced coagulopathy. This project intends to prospectively observe the changes in gut microbiome dysbiosis and blood coagulation function in patients with sepsis before and after treatment, and explore whether the changes in gut microbiome dysbiosis promote the development of sepsis through coagulation disorders, provide new research perspectives for diagnosis and treatment for sepsis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy
    Actual Study Start Date :
    Jul 15, 2020
    Anticipated Primary Completion Date :
    Jul 15, 2021
    Anticipated Study Completion Date :
    Jul 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Gut Microbiome alterations [Day 1- Day 14]

      Taxonomic alterations,bacterial alpha diversity alterations,beta-diversity alterations of gut microbiome by performing metagenomic sequencing analysis of fecal samples

    2. coagulation disorder tests [Day 1- Day 14]

      Laboratory tests of coagulation disorder,such as PT,APTT,INR,TEG,fibrin degradation products , D-dimers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥18 years and ≤85 years

    • Sign the informed consent form

    • Expected ICU hospital stay> 24 hours

    • △SOFA score ≥2 and confirmed or suspected infection

    Exclusion Criteria:

    • Pregnant or breastfeeding women

    • Estimated survival time <24 hours

    • Diagnosis of sepsis time> 24 hours

    • The length of ICU stay before diagnosis of sepsis> 7 days

    • Sepsis from which the source of infection cannot be determined

    • Congenital coagulopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510120

    Sponsors and Collaborators

    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Investigators

    • Study Chair: minggen Zhou, Department of Intensive Care Unit, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhi-jie He, Clinical Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT04525677
    Other Study ID Numbers:
    • SYSEC-KY-KS-2020-107
    First Posted:
    Aug 25, 2020
    Last Update Posted:
    Aug 25, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis
    Toxemia
    Dysbiosis

    Study Results

    No Results Posted as of Aug 25, 2020