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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
28-day all-cause mortality
All-cause mortality assessed within 28 days after admission to the intensive care unit.
Secondary outcomes
ICU length of stay
From ICU admission to ICU discharge
Organ dysfunction
Within 28 days after ICU admission
Secondary infection
Secondary infection during ICU stay
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.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: