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Myeloid-derived Suppressor Cells in Sepsis

Sponsor
Chung Fu-Tsai (Other)
Overall Status
Recruiting
CT.gov ID
NCT03540797
Collaborator
(none)
125
Enrollment
1
Location
102
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed for septic patients, to isolate MDSCs and the correlation of prognosis of sepsis. The purpose of this study hopes to explore the phenomenon and possible mechanisms of MDSCs in patients with severe sepsis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    125 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Roles of MDSCs (Myeloid-derived Suppressor Cells) in Adult Patients With Sepsis.
    Actual Study Start Date :
    Jul 1, 2015
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Intensive care unit (ICU) patients with sepsis

    Outcome Measures

    Primary Outcome Measures

    1. Survival of Intensive care unit (ICU) stay [28 days]

    Secondary Outcome Measures

    1. In hospital survival [90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have known origin of infection .

    • Systemic inflammatory response syndrome.

    Exclusion Criteria:

    • age less than 18 years

    • pregnancy

    • known anaphylactoid reaction to colloid fluids

    • a life expectancy less than 24 hours,

    • inability to provide informed, written consent

    • Patients receiving nephrotoxic drugs,

    • admitted to the hospital following a surgical procedure,

    • sepsis more than 72 hours when screening .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chung Gung Memorial Hospital Linkou Taiwan 333

    Sponsors and Collaborators

    • Chung Fu-Tsai

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chung Fu-Tsai, Attending physician, Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT03540797
    Other Study ID Numbers:
    • IRB103-6424B
    First Posted:
    May 30, 2018
    Last Update Posted:
    May 31, 2018
    Last Verified:
    May 1, 2018
    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 31, 2018