Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Dr… (NCT07353970) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mechanisms of Prognostic Regulation andPrecision Phenotype Ldentification in Severe Infections Driven by SpecializedPro-Resolving Mediators
300 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
28-day all-cause mortality
Timeframe: From the date of ICU admission until death from any cause, assessed up to 28 days
Trial details
NCT IDNCT07353970
SponsorSecond Affiliated Hospital of Wenzhou Medical University