An observational study in Sepsis, Severe Infection and Multiple Organ Dysfunction Syndrome, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational
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.
Severe infection and sepsis remain leading causes of morbidity and mortality worldwide. Although antimicrobial therapy and organ support have improved, many critically ill patients continue to experience poor outcomes. Increasing evidence indicates that failure to appropriately resolve inflammation plays a key role in organ dysfunction and mortality. Specialized pro-resolving mediators (SPMs) are endogenous lipid mediators that actively terminate inflammation, promote clearance of pathogens and apoptotic cells, and support tissue repair. However, their role in human severe infection has not been systematically investigated in prospective clinical cohorts.
This study is a prospective observational cohort study enrolling adult patients with severe infection admitted to the intensive care unit (ICU). Approximately 300 patients are expected to be included. Peripheral blood samples obtained during routine clinical care on days 1, 3, and 7 after ICU admission will be analyzed. Plasma SPMs, including resolvins, protectins, and maresins, will be quantified using liquid chromatography-tandem mass spectrometry. Routine clinical data, including demographic characteristics, laboratory tests, immune cell subsets, coagulation indicators, severity scores (SOFA and APACHE II), organ support therapies, and 28-day outcomes will be recorded.
The study has four major objectives:
to describe the temporal profiles of SPMs in severe infection
to determine associations between SPM levels and adverse outcomes including 28-day mortality and organ failure
to identify biologically and clinically meaningful phenotypes driven by SPM signatures through multivariate clustering and machine-learning approaches
to explore mechanistic pathways linking SPMs with immune responses, coagulation disturbances, organ dysfunction, and clinical prognosis
No experimental medications or interventional procedures are administered as part of this study. All treatments are determined exclusively by the treating physicians according to routine clinical practice. No genetic testing or DNA extraction will be performed from collected samples.
The expected outcome of this study is the development of an SPM-based precision phenotyping framework that may support individualized risk assessment and potential future therapeutic strategies targeting impaired inflammation resolution.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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.
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
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared because the study involves sensitive clinical information, and data sharing is not covered by the current ethics approval. Data will be used solely for the purposes specified in the approved study protocol.
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Dec 2026, 11 months later.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 11 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University →