An observational study in Sepsis, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational
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.
This study is a prospective observational cohort study conducted in adult patients with severe infection who are admitted to the intensive care unit (ICU). The study aims to characterize dynamic changes in immune cell profiles during critical illness and to examine how these changes are associated with short-term clinical outcomes.
Severe infection, including sepsis, is frequently accompanied by profound alterations in immune function. While some individuals recover, others develop persistent organ dysfunction or die despite standard medical care. Current clinical and laboratory markers provide limited information about immune status and do not reliably predict outcomes. A more detailed understanding of immune cell patterns in critically ill patients may help improve risk stratification and future clinical decision-making.
Adult patients (aged 18 years or older) who are diagnosed with severe infection according to established clinical criteria and admitted to the ICU will be screened for eligibility. Participants will be enrolled consecutively after informed consent is obtained from the patient or a legally authorized representative. This study does not involve any experimental intervention, and all participants will receive standard medical care as determined by their treating clinicians.
Peripheral blood samples will be collected at predefined time points during the ICU stay, including early and later phases of illness. These samples will be used to assess immune cell populations and their activation states using established laboratory methods. In addition, routinely collected clinical data will be recorded, including demographic information, severity of illness scores, laboratory test results, organ support measures, and clinical outcomes.
The primary clinical outcome of interest is all-cause mortality within 28 days after ICU admission. Secondary outcomes include the development of organ dysfunction and length of ICU stay. Immune cell data will be analyzed in relation to these outcomes to identify immune patterns that are associated with different clinical trajectories.
Statistical analyses will focus on describing immune cell distributions, identifying immune phenotypes using data-driven approaches, and evaluating associations between immune patterns and clinical outcomes while accounting for relevant clinical variables. The results of this study are intended to improve understanding of immune alterations in severe infection and to inform future research aimed at improving prognosis assessment and patient management.
All data will be collected and stored in accordance with ethical and regulatory requirements. Participant confidentiality will be maintained through coded identifiers, and access to identifiable information will be restricted to authorized study personnel.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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
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.
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.
Secondary infection
Secondary infection during ICU stay
Time frame: Within 28 days after ICU admission
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
Molecular phenotypes of immune cells
Molecular phenotypes of peripheral immune cell subsets, will be assessed by multiparameter flow cytometry.
Time frame: At ICU admission and during ICU stay
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared because the study involves sensitive clinical information, and data sharing is not covered by the current ethics approval. Data will be used solely for the purposes specified in the approved study protocol.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University