Mechanisms of Precise Immune Cell Phenotyping and Prognostic Prediction in Severe Infection

NCT07332793 | Not Yet Recruiting DMC

• 1 other identifier: SAHoWMU-CR2025-03-137
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn how changes in immune cells are linked to outcomes in adults with severe infection who are treated in the intensive care unit (ICU). Severe infections, including sepsis, can affect how the immune system works and may lead to poor recovery or death. Researchers want to better understand these immune changes so that people at higher risk can be identified earlier. The main questions this study aims to answer are: Are certain immune cell patterns linked to survival or death within 28 days? Are these immune patterns linked to organ failure or longer stays in the ICU? Participants will be adults with severe infection who are admitted to the ICU as part of their routine medical care. This study does not change or add to their medical treatment. Participants will: Have small blood samples collected at several time points during their ICU stay Allow researchers to review their medical records, including test results and outcomes Researchers will analyze immune cells in the blood and relate these findings to clinical outcomes. The results may help improve future risk assessment and understanding of immune changes in people with severe infection.

Conditions

Sepsis

Keywords

immune cells; Sepsis

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  All-cause mortality assessed within 28 days after admission to the intensive care unit.

  Within 28 days after ICU admission

Secondary Outcomes (5)

• ICU length of stay

  Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.

• Organ dysfunction

  Organ dysfunction assessed using routinely collected clinical data during the first 28 days after ICU admission.

• Secondary infection

  Within 28 days after ICU admission

• GPCR Expression on Regulatory T Cells

  At baseline (ICU admission), Day 7, and Day 14

• Molecular phenotypes of immune cells

  At ICU admission and during ICU stay

Study Arms (1)

Severe Infection ICU Cohort

Adult patients with severe infection admitted to the intensive care unit (ICU). All participants receive standard clinical care as determined by their treating physicians. No experimental interventions are assigned.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years or older who are admitted to the intensive care unit (ICU) with severe infection, including sepsis. Participants are enrolled during the early phase of ICU admission and receive standard clinical care as determined by their treating physicians. This observational study does not involve assignment to experimental interventions.

You may qualify if:

• Adults aged 18 years or older
• Admission to the intensive care unit (ICU)
• Diagnosis of severe infection, including sepsis, based on established clinical criteria
• Enrollment within the early phase of ICU admission
• Informed consent obtained from the patient or a legally authorized representative

You may not qualify if:

• Age younger than 18 years
• Pregnancy or breastfeeding
• Known history of hematologic malignancy or active solid malignancy receiving chemotherapy
• Known primary immunodeficiency or long-term immunosuppressive therapy prior to ICU admission
• Human immunodeficiency virus (HIV) infection with severe immunosuppression
• Previous enrollment in this study
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples collected during routine clinical care, retained for immune cell analysis and related laboratory assessments. No samples will be used for DNA extraction or genetic analysis.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shengwei Jin, PHD

CONTACT

+86-15068468153; jinshengwei69@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion: January 16, 2026
• Study Completion (Estimated): January 15, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share