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

ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Severe Infection ICU Cohort

Trial outcomes

Primary outcomes

1

28-day all-cause mortality

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

Time frame
Within 28 days after ICU admission

Secondary outcomes

1

ICU length of stay

From ICU admission to ICU discharge

Time frame
Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
2

Organ dysfunction

Within 28 days after ICU admission

Time frame
Organ dysfunction assessed using routinely collected clinical data during the first 28 days after ICU admission.
3

Secondary infection

Secondary infection during ICU stay

Time frame
Within 28 days after ICU admission
4

GPCR Expression on Regulatory T Cells

The expression levels of selected G protein-coupled receptors (GPCRs) on peripheral blood regulatory T cells (Tregs), quantified by flow cytometry and expressed as mean fluorescence intensity (MFI) and/or percentage of positive cells.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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