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

NCT05126537 | Unknown DMC

• 1 other identifier: 2020ZDSYLL041-Y01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

28 Day Mortality

Keywords

sepsis immunosuppression Treg

Outcome Measures

Primary Outcomes (1)

• 28 day mortality

  all patients followed up to 28 days

  28 days

Study Arms (3)

Health volunteers

Health volunteers as control group

Other: no intervention

ICU non-sepsis patients

ICU non-sepsis patients as control group

Other: no intervention

Sepsis patients

Sepsis patients as study group

Other: no intervention

Interventions

no intervention OTHER

prospective and observational study with no intervention

Health volunteers; ICU non-sepsis patients; Sepsis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with sepsis

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood was extracted according to time points and stored

Study Officials

• Qingxiang Liu, MD.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songqiao Liu, MD. PhD.

CONTACT

086-2583262550; liusongqiao@ymail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CN (1)