About this trial
This is a prospective observational study involving adult patients with severe infection who are admitted to the intensive care unit (ICU). Severe infection and sepsis are major causes of death worldwide. Many patients experience uncontrolled inflammation or immune suppression, but current tests are limited in identifying which patients are at highest risk.
This study focuses on specialized pro-resolving mediators (SPMs), a group of naturally occurring lipid molecules that help the body turn off inflammation and promote healing. Blood samples that are collected during routine clinical care will be used to measure levels of SPMs. No additional blood draws or experimental treatments will be performed.
The purpose of this study is to understand how SPM levels change over time in patients with severe infection and how these changes relate to organ function and outcomes such as survival. By combining SPM measurements with routine laboratory results, immune cell counts, and imaging findings, the study aims to identify different clinical phenotypes and to develop tools that may help doctors recognize high-risk patients earlier in the future.
All participants will receive standard medical care determined by their treating physicians. No experimental drugs or interventions are given as part of this study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Admission to the intensive care unit (ICU)
Diagnosis of severe infection or sepsis, as determined by the treating physician according to current clinical criteria
Ability to obtain blood samples as part of routine clinical care within 24-48 hours after ICU admission
Disqualifiers
Known pregnancy
Known immunosuppressive disease (e.g., hematologic malignancy, advanced HIV infection)
Use of long-term immunosuppressive therapy or systemic corticosteroids prior to ICU admission
Pre-existing end-stage disease with expected survival < 28 days (e.g., end-stage cancer receiving palliative care)
Trial population
Adult ICU patients with severe infection or sepsis admitted to a tertiary academic medical center. Both male and female patients aged 18 years or older are eligible. All participants receive standard clinical care, and no experimental treatments are provided within this study.
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
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 during ICU stay
Secondary infection defined as a newly diagnosed infection occurring after ICU admission, confirmed by clinical signs, microbiological evidence, and/or initiation of targeted antimicrobial therapy, based on routinely collected clinical data.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: