Co-inhibitory Molecules on Treg and miR-155-5p in Patients With Sepsis

NCT ID: NCT05126537

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-31

Brief Summary

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there is high mortality rate of sepsis, 36% in 90-days of sepsis in China, and there is no effective treatment. Immunosuppression mediated by sepsis is an important cause of death in patients. Treg cells are important immunomodulatory cell. Treg's over-differentiation is involved in the development of sepsis induced immunosuppression. In sepsis patients, the expression of PD-1、CTLA-4 and TIGIT on Treg cell surface increased, and Treg cells with high expression of co-inhibitory molecules showed stronger immunosuppressive characteristics. MiR-155-5p is an unencoded RNA transcript from a proto-oncogene B cell integration cluster. In sepsis, the expression of miR-155 increased in peripheral blood and correlated with the patient's prognosis. Recent studies have shown that miR-155-5p promotes co-inhibitory molecules expressed on T cells in LCMV infected animal models. However, the relationship between the expression of peripheral blood miR-155-5p in sepsis patients and the expression of co-inhibitory molecules on Treg cell surface is not clear.

Detailed Description

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1. peripheral blood Treg cells and their surface PD-1、CTLA-4 and TIGIT levels in sepsis patients were measured by flowcytometry. SOFA score、APACHE II score were recorded
2. the level of miR-155-5p were measured by RT-qPCR in patients with sepsis on day 0-1 and day 3-5, and the correlation between the expression of the co-inhibitory molecules and miR-155-5p were evaluated

Conditions

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28 Day Mortality

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Health volunteers

Health volunteers as control group

no intervention

Intervention Type OTHER

prospective and observational study with no intervention

ICU non-sepsis patients

ICU non-sepsis patients as control group

no intervention

Intervention Type OTHER

prospective and observational study with no intervention

Sepsis patients

Sepsis patients as study group

no intervention

Intervention Type OTHER

prospective and observational study with no intervention

Interventions

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no intervention

prospective and observational study with no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* sepsis 3.0 diagnositic criteria are met. older than 18 years old. total course is less than 7 days. Informed consent is obatained.

Exclusion Criteria

* pregnancy. patients with active malignant tumors. chronic hepatitis or HIV. patients under treatment with immunosuppressive drugs (except patients with glucocorticosteroid prednisone or equivalent dose\<10 mg/d per day)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Songqiao Liu

Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingxiang Liu, MD.

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Songqiao Liu, MD. PhD.

Role: CONTACT

086-2583262550

Facility Contacts

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Songqiao Liu, MD. PhD.

Role: primary

Haibo Qiu, MD. PhD.

Role: backup

Other Identifiers

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2020ZDSYLL041-Y01

Identifier Type: -

Identifier Source: org_study_id

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