SepsisPIC-PSINCT07332793
Mechanisms of Precise Immune Cell Phenotyping and Prognostic Prediction in Severe Infection
An observational study of Sepsis, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
The goal of this observational study is to learn how changes in immune cells are linked to outcomes in adults with severe infection who are treated in the intensive care unit (ICU). Severe infections, including sepsis, can affect how the immune system works and may lead to poor recovery or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years or older who are admitted to the intensive care unit (ICU) with severe infection, including sepsis. Participants are enrolled during the early phase of ICU admission and receive standard clinical care as determined by their treating physicians. This observational study does not involve assignment to experimental interventions.
Who may be able to join
- Adults aged 18 years or older
- Admission to the intensive care unit (ICU)
- Diagnosis of severe infection, including sepsis, based on established clinical criteria
- Enrollment within the early phase of ICU admission
- Informed consent obtained from the patient or a legally authorized representative
Who cannot join
- Age younger than 18 years
- Pregnancy or breastfeeding
- Known history of hematologic malignancy or active solid malignancy receiving chemotherapy
- Known primary immunodeficiency or long-term immunosuppressive therapy prior to ICU admission
- Human immunodeficiency virus (HIV) infection with severe immunosuppression
- Previous enrollment in this study
- Refusal or inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn how changes in immune cells are linked to outcomes in adults with severe infection who are treated in the intensive care unit (ICU). Severe infections, including sepsis, can affect how the immune system works and may lead to poor recovery or death. Researchers want to better understand these immune changes so that people at higher risk can be identified earlier.
The main questions this study aims to answer are:
Read more
Are certain immune cell patterns linked to survival or death within 28 days? Are these immune patterns linked to organ failure or longer stays in the ICU? Participants will be adults with severe infection who are admitted to the ICU as part of their routine medical care. This study does not change or add to their medical treatment.
Participants will:
Have small blood samples collected at several time points during their ICU stay Allow researchers to review their medical records, including test results and outcomes Researchers will analyze immune cells in the blood and relate these findings to clinical outcomes. The results may help improve future risk assessment and understanding of immune changes in people with severe infection.
Read the detailed description
This study is a prospective observational cohort study conducted in adult patients with severe infection who are admitted to the intensive care unit (ICU). The study aims to characterize dynamic changes in immune cell profiles during critical illness and to examine how these changes are associated with short-term clinical outcomes.
Severe infection, including sepsis, is frequently accompanied by profound alterations in immune function. While some individuals recover, others develop persistent organ dysfunction or die despite standard medical care. Current clinical and laboratory markers provide limited information about immune status and do not reliably predict outcomes. A more detailed understanding of immune cell patterns in critically ill patients may help improve risk stratification and future clinical decision-making.
Adult patients (aged 18 years or older) who are diagnosed with severe infection according to established clinical criteria and admitted to the ICU will be screened for eligibility. Participants will be enrolled consecutively after informed consent is obtained from the patient or a legally authorized representative. This study does not involve any experimental intervention, and all participants will receive standard medical care as determined by their treating clinicians.
Peripheral blood samples will be collected at predefined time points during the ICU stay, including early and later phases of illness. These samples will be used to assess immune cell populations and their activation states using established laboratory methods. In addition, routinely collected clinical data will be recorded, including demographic information, severity of illness scores, laboratory test results, organ support measures, and clinical outcomes.
The primary clinical outcome of interest is all-cause mortality within 28 days after ICU admission. Secondary outcomes include the development of organ dysfunction and length of ICU stay. Immune cell data will be analyzed in relation to these outcomes to identify immune patterns that are associated with different clinical trajectories.
Statistical analyses will focus on describing immune cell distributions, identifying immune phenotypes using data-driven approaches, and evaluating associations between immune patterns and clinical outcomes while accounting for relevant clinical variables. The results of this study are intended to improve understanding of immune alterations in severe infection and to inform future research aimed at improving prognosis assessment and patient management.
All data will be collected and stored in accordance with ethical and regulatory requirements. Participant confidentiality will be maintained through coded identifiers, and access to identifiable information will be restricted to authorized study personnel.
- Conditions
- Sepsis
- Keywords
- immune cells, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Infection ICU Cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
All-cause mortality assessed within 28 days after admission to the intensive care unit.
Measured: Within 28 days after ICU admission
Secondary outcomes (5)
ICU length of stay
From ICU admission to ICU discharge
Measured: Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
Organ dysfunction
Within 28 days after ICU admission
Measured: Organ dysfunction assessed using routinely collected clinical data during the first 28 days after ICU admission.
Secondary infection
Secondary infection during ICU stay
Measured: Within 28 days after ICU admission
GPCR Expression on Regulatory T Cells
The expression levels of selected G protein-coupled receptors (GPCRs) on peripheral blood regulatory T cells (Tregs), quantified by flow cytometry and expressed as mean fluorescence intensity (MFI) and/or percentage of positive cells.
Measured: At baseline (ICU admission), Day 7, and Day 14
Molecular phenotypes of immune cells
Molecular phenotypes of peripheral immune cell subsets, will be assessed by multiparameter flow cytometry.
Measured: At ICU admission and during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion16 Jan 2026 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332793
- Sponsor's protocol ID
- SAHoWMU-CR2025-03-137
- Acronym
- PIC-PSI
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Precise Immune Cell Phenotyping and Prognostic Prediction in Severe Infection
- ClinicalTrials.gov ID
- NCT07332793
- Acronym / sponsor ID
- PIC-PSI / SAHoWMU-CR2025-03-137
- Conditions
- Sepsis
- Keywords
- immune cells, Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 16 Jan 2026 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn how changes in immune cells are linked to outcomes in adults with severe infection who are treated in the intensive care unit (ICU). Severe infections, including sepsis, can affect how the immune system works and may lead to poor recovery or death. Researchers want to better understand these immune changes so that people at higher risk can be identified earlier.
The main questions this study aims to answer are:
Are certain immune cell patterns linked to survival or death within 28 days? Are these immune patterns linked to organ failure or longer stays in the ICU? Participants will be adults with severe infection who are admitted to the ICU as part of their routine medical care. This study does not change or add to their medical treatment.
Participants will:
Have small blood samples collected at several time points during their ICU stay Allow researchers to review their medical records, including test results and outcomes Researchers will analyze immune cells in the blood and relate these findings to clinical outcomes. The results may help improve future risk assessment and understanding of immune changes in people with severe infection.
Detailed description
This study is a prospective observational cohort study conducted in adult patients with severe infection who are admitted to the intensive care unit (ICU). The study aims to characterize dynamic changes in immune cell profiles during critical illness and to examine how these changes are associated with short-term clinical outcomes.
Severe infection, including sepsis, is frequently accompanied by profound alterations in immune function. While some individuals recover, others develop persistent organ dysfunction or die despite standard medical care. Current clinical and laboratory markers provide limited information about immune status and do not reliably predict outcomes. A more detailed understanding of immune cell patterns in critically ill patients may help improve risk stratification and future clinical decision-making.
Adult patients (aged 18 years or older) who are diagnosed with severe infection according to established clinical criteria and admitted to the ICU will be screened for eligibility. Participants will be enrolled consecutively after informed consent is obtained from the patient or a legally authorized representative. This study does not involve any experimental intervention, and all participants will receive standard medical care as determined by their treating clinicians.
Peripheral blood samples will be collected at predefined time points during the ICU stay, including early and later phases of illness. These samples will be used to assess immune cell populations and their activation states using established laboratory methods. In addition, routinely collected clinical data will be recorded, including demographic information, severity of illness scores, laboratory test results, organ support measures, and clinical outcomes.
The primary clinical outcome of interest is all-cause mortality within 28 days after ICU admission. Secondary outcomes include the development of organ dysfunction and length of ICU stay. Immune cell data will be analyzed in relation to these outcomes to identify immune patterns that are associated with different clinical trajectories.
Statistical analyses will focus on describing immune cell distributions, identifying immune phenotypes using data-driven approaches, and evaluating associations between immune patterns and clinical outcomes while accounting for relevant clinical variables. The results of this study are intended to improve understanding of immune alterations in severe infection and to inform future research aimed at improving prognosis assessment and patient management.
All data will be collected and stored in accordance with ethical and regulatory requirements. Participant confidentiality will be maintained through coded identifiers, and access to identifiable information will be restricted to authorized study personnel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Infection ICU Cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older who are admitted to the intensive care unit (ICU) with severe infection, including sepsis. Participants are enrolled during the early phase of ICU admission and receive standard clinical care as determined by their treating physicians. This observational study does not involve assignment to experimental interventions.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Admission to the intensive care unit (ICU)
- Diagnosis of severe infection, including sepsis, based on established clinical criteria
- Enrollment within the early phase of ICU admission
- Informed consent obtained from the patient or a legally authorized representative
Key exclusion criteria (7 listed)
- Age younger than 18 years
- Pregnancy or breastfeeding
- Known history of hematologic malignancy or active solid malignancy receiving chemotherapy
- Known primary immunodeficiency or long-term immunosuppressive therapy prior to ICU admission
- Human immunodeficiency virus (HIV) infection with severe immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day all-cause mortality
Time frame: Within 28 days after ICU admission
All-cause mortality assessed within 28 days after admission to the intensive care unit.
5 secondary outcomes
ICU length of stay
Time frame: Length of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
Organ dysfunction
Time frame: Organ dysfunction assessed using routinely collected clinical data during the first 28 days after ICU admission.
Secondary infection
Time frame: Within 28 days after ICU admission
GPCR Expression on Regulatory T Cells
Time frame: At baseline (ICU admission), Day 7, and Day 14
Molecular phenotypes of immune cells
Time frame: At ICU admission and during ICU stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Second Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengwei Jin, PHD (+86-15068468153, jinshengwei69@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: Within 28 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.