Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro-Resolving Mediators

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSecond Affiliated Hospital of Wenzhou Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Severe Infection ICU Cohort Adult patients

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
From the date of ICU admission until death from any cause, assessed up to 28 days

Secondary outcomes

1

ICU length of stay

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

Time frame
From ICU admission to ICU discharge, assessed up to 28 days.
2

Organ dysfunction

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

Time frame
Organ dysfunction assessed using routinely collected clinical data from ICU admission through day 28.
3

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.

Time frame
From the date of ICU admission until the occurrence of a secondary infection or ICU discharge, whichever occurred first, assessed up to 28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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