EIPPSM: Early Identification and Prognosis Prediction of Sepsis Through Multiomics

Sponsor
Yantai Yuhuangding Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05305469
Collaborator
(none)
900
1
36
25

Study Details

Study Description

Brief Summary

This study aims to integrate multi-omics data and clinical indicators to reveal pathogen-specific molecular patterns in patients with sepsis and establish prognostic prediction models through multiple machine learning algorithms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study aims to quantify the plasma metabolome, single nucleotide polymorphisms (SNPs) of exons and immunocytokines of septic patients with different pathogen infections and prognostic outcomes. Multi-omics data, cytokines, and clinical indicators will be integrated through multiple machine learning algorithms to reveal pathogen-specific molecular patterns and multi-dimensional prognostic prediction models.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Early Identification and Prognosis Prediction of Sepsis Through Multiomics
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    GN

    Gram-negative bacteria infection group

    GP

    Gram-positive bacteria infection group

    Fungal

    Fungal infection group

    Viral

    Viral infection group

    Control

    Non-sepsis group

    Outcome Measures

    Primary Outcome Measures

    1. Pathogen-specific patterns [March 2022 - December 2023]

      To elucidate the unique infection pathogen-specific molecular patterns in septic patients

    Secondary Outcome Measures

    1. Prognostic prediction models [March 2022 - December 2024]

      To establish the models using multi-omics data to predict the prognosis of sepsis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with sepsis or septic shock who meet the diagnostic criteria (2016 sepsis 3.0 standard);

    • Age 18~85 years old.

    Exclusion Criteria:
    • ICU stay of the subjects less than 72 hours;

    • Female subjects who are pregnant;

    • The subjects not sure if infected;

    • The subjects performed CPR;

    • The subjects suffer from chronic renal disease;

    • The subjects with incomplete clinical data.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yantai Yuhuangding Hospital Yantai Shandong China 264000

    Sponsors and Collaborators

    • Yantai Yuhuangding Hospital

    Investigators

    • Principal Investigator: Jing Wang, Yantai Yuhuangding Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yantai Yuhuangding Hospital
    ClinicalTrials.gov Identifier:
    NCT05305469
    Other Study ID Numbers:
    • 2022-031
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 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 Yantai Yuhuangding Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022