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

Sponsor

Southeast University, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05126537

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
28 Day Mortality	Other: no intervention

Detailed Description

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
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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

An Observational Study on the Relationship Between Expression of Co-inhibitory Molecules on Treg and miR-155-5p Expression in the Peripheral Blood of Patients With Sepsis

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
health volunteers	Other: no intervention prospective and observational study with no intervention
ICU non-sepsis patients	Other: no intervention prospective and observational study with no intervention
sepsis patients	Other: no intervention prospective and observational study with no intervention

Arm

Intervention/Treatment

health volunteers

Other: no intervention

prospective and observational study with no intervention

ICU non-sepsis patients

Other: no intervention

prospective and observational study with no intervention

sepsis patients

Other: no intervention

prospective and observational study with no intervention

Outcome Measures

Primary Outcome Measures

28 day mortality [28 days]
all patients followed up to 28 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Southeast University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Songqiao Liu, Chief, Southeast University, China

ClinicalTrials.gov Identifier:

NCT05126537

Other Study ID Numbers:

2020ZDSYLL041-Y01

First Posted:

Nov 19, 2021

Last Update Posted:

Jan 4, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Songqiao Liu, Chief, Southeast University, China

sepsis immunosuppression Treg

Additional relevant MeSH terms:

Sepsis

Study Results

No Results Posted as of Jan 4, 2022