TRIM25 in Septic Patients

Expression of Trim25 in Peripheral Blood Mononuclear Cells of Patients With Sepsis and Non-sepsis and Its Relationship With the Prognosis of Patients With Sepsis

Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, which can lead to organ damage and failure. The goal of this observational study is to better understand the underlying biological changes that occur in patients with sepsis compared to those who do not have the condition.

We will collect peripheral blood samples from patients diagnosed with sepsis and from non-sepsis control participants. From these samples, we will isolate peripheral blood mononuclear cells (PBMCs) and serum.

We will then analyze these components to measure the activity of specific genes and the levels of key inflammatory factors (cytokines).

The information we gather will help researchers identify molecular and inflammatory markers associated with sepsis. This knowledge is crucial for developing new and more effective methods for diagnosing and treating this critical illness.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: Gene and Inflammatory Marker Analysis in Sepsis

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population will consist of two primary, non-overlapping groups of adult participants recruited from the hospital setting:

Sepsis Patient Cohort (Case Group): Adult patients (aged 18 years or older) who are diagnosed with Sepsis based on the Sepsis-3 clinical criteria (or the most current widely accepted clinical definitions) upon admission to the Intensive Care Unit (ICU) or general ward.

Non-Sepsis Control Cohort (Control Group): Adult patients (aged 18 years or older) who are admitted to the hospital with non-infectious conditions or healthy volunteers, provided they do not meet the criteria for sepsis or severe infection at the time of enrollment.

The enrollment process for both groups will be observational, involving the collection of a single peripheral blood sample for the isolation of peripheral blood mononuclear cells (PBMCs) and serum, as well as collection of relevant clinical data.

Description

Inclusion Criteria:

• 1. SOFA score >=2; 2. Aged 18-70 years male and female; 3. Hospitalization.

Exclusion Criteria:

• 1. Immune system disease, such as HIV; 2. Disease that possibly affect the function of immune system, such as tumor and chronic viral infection; 3. Patients that treated with massive cortical hormone (>200mg/d) or immunosuppressant; 4. Pregnant or lactation women.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-sepsis patients; Sepsis patients	Diagnostic test: Gene and Inflammatory Marker Analysis in Sepsis; 1.Sepsis Group: SOFA score >=2;; Aged 18-70 years male and female;; Hospitalization. 2.Non-sepsis Group: (1) Healthy adults; (2) Aged 18-70 years male and female.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRIM25 in PBMCs	We will collect peripheral blood mononuclear cells (PBMCs) from both sepsis patients and non-sepsis control patients to compare the expression level of the TRIM25 gene in these cells.	From 2021.12 to 2026.06

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Genes
• Other Study ID Numbers: Sepsis-2021-278; 81900073 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No