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

NCT07353970 | Not Yet Recruiting DMC

• 1 other identifier: SAHoWMU-CR2025-03-135
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Organ Dysfunction Syndrome; Critical Illness; Sepsis; Severe Infection

Keywords

Specialized pro-resolving mediators; SPM; Resolvin D1; Immune resolution; Inflammation resolution; Critical care

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

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

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

Secondary Outcomes (3)

• ICU length of stay

  From ICU admission to ICU discharge, assessed up to 28 days.

• Organ dysfunction

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

• Secondary infection during ICU stay

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

Study Arms (1)

Severe Infection ICU Cohort Adult patients

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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
• Informed consent provided by the patient or legally authorized representative (when applicable)

You may not qualify if:

• 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)
• Enrollment in interventional clinical trials that may influence immune or inflammatory responses
• Refusal of informed consent by the patient or legal representative
• Patients in whom blood sampling or follow-up is not feasible (e.g., expected transfer, withdrawal of life-sustaining treatment within 24 hours)

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples collected during routine clinical care will be used for the analysis of specialized pro-resolving mediators and related laboratory assessments. No samples will be used for DNA extraction or genetic analysis.

MeSH Terms

Conditions

Sepsis; Infections; Multiple Organ Failure; Critical Illness

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Central Study Contacts

Shengwei Jin, PhD

CONTACT

+86-15068468153; jinshengwei69@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): January 16, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share