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SLL: Dissecting How Peripheral Lymphocytes Are Lost During Sepsis

Sponsor
Southeast University, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT03289312
Collaborator
(none)
54
Enrollment
1
Location
11.6
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics：

    ①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    54 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Dissecting How Peripheral Lymphocytes Are Lost During Sepsis
    Anticipated Study Start Date :
    Jan 11, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Dec 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Sepsis

    Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
    Health control

    Health vonlunteers

    Outcome Measures

    Primary Outcome Measures

    1. lymphocyte loss [day of inclussion and 7th day after inclussion]

      ratios of T cells loss by different mechanism in different subgroups

    Secondary Outcome Measures

    1. prognosis [28-day after inclussion]

      28-day prognosis:survive or not

    2. Complicated organ dysfunction [during 28 days after inclussion]

      duration and surpport therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Health volunteers
    Exclusion Criteria:
    • History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongda Hospital Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Southeast University, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianfeng Xie, Southeast University, China, Southeast University, China
    ClinicalTrials.gov Identifier:
    NCT03289312
    Other Study ID Numbers:
    • 2017ZDSYSLLoss
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Dec 27, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jianfeng Xie, Southeast University, China, Southeast University, China
    sepsis, lymphocyte
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Dec 27, 2017