SepsisNCT07320638
TRIM25 in Septic Patients
An observational study of Sepsis, run by Ruijin Hospital at 1 site in China.
Trial summary
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, which can lead to organ damage and failure. The goal of this observational study is to better understand the underlying biological changes that occur in patients with sepsis compared to those who do not have the condition. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Gene and Inflammatory Marker Analysis in Sepsis
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 1 Jul 2026
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of two primary, non-overlapping groups of adult participants recruited from the hospital setting: Sepsis Patient Cohort (Case Group): Adult patients (aged 18 years or older) who are diagnosed with Sepsis based on the Sepsis-3 clinical criteria (or the most current widely accepted clinical definitions) upon admission to the Intensive Care Unit (ICU) or general ward. Non-Sepsis Control Cohort (Control Group): Adult patients (aged 18 years or older) who are admitted to the hospital with non-infectious conditions or healthy volunteers, provided they do not meet the criteria for sepsis or severe infection at the time of enrollment. The enrollment process for both groups will be observational, involving the collection of a single peripheral blood sample for the isolation of peripheral blood mononuclear cells (PBMCs) and serum, as well as collection of relevant clinical data.
Who may be able to join
- 1. SOFA score >=2; 2. Aged 18-70 years male and female; 3. Hospitalization.
Who cannot join
- 1. Immune system disease, such as HIV; 2. Disease that possibly affect the function of immune system, such as tumor and chronic viral infection; 3. Patients that treated with massive cortical hormone (>200mg/d) or immunosuppressant; 4. Pregnant or lactation women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Expression of Trim25 in Peripheral Blood Mononuclear Cells of Patients With Sepsis and Non-sepsis and Its Relationship With the Prognosis of Patients With Sepsis
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, which can lead to organ damage and failure. The goal of this observational study is to better understand the underlying biological changes that occur in patients with sepsis compared to those who do not have the condition.
We will collect peripheral blood samples from patients diagnosed with sepsis and from non-sepsis control participants. From these samples, we will isolate peripheral blood mononuclear cells (PBMCs) and serum.
Read more
We will then analyze these components to measure the activity of specific genes and the levels of key inflammatory factors (cytokines).
The information we gather will help researchers identify molecular and inflammatory markers associated with sepsis. This knowledge is crucial for developing new and more effective methods for diagnosing and treating this critical illness.
- Conditions
- Sepsis
- Being tested
- Gene and Inflammatory Marker Analysis in Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene and Inflammatory Marker Analysis in SepsisDiagnostic test
1.Sepsis Group:
- SOFA score >=2;
- Aged 18-70 years male and female;
- Hospitalization. 2.Non-sepsis Group: (1) Healthy adults; (2) Aged 18-70 years male and female.
| Study group | Role | What they receive |
|---|---|---|
| Non-sepsis patients | Sepsis patients Receives: Diagnostic Test: Gene and Inflammatory Marker Analysis in Sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRIM25 in PBMCs
We will collect peripheral blood mononuclear cells (PBMCs) from both sepsis patients and non-sepsis control patients to compare the expression level of the TRIM25 gene in these cells.
Measured: From 2021.12 to 2026.06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start10 Dec 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (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 Ruijin HospitalThe 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320638
- Sponsor's protocol ID
- Sepsis-2021-278
- Other IDs
- 81900073
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Trim25 in Peripheral Blood Mononuclear Cells of Patients With Sepsis and Non-sepsis and Its Relationship With the Prognosis of Patients With Sepsis
- ClinicalTrials.gov ID
- NCT07320638
- Acronym / sponsor ID
- Sepsis-2021-278
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 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.
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, which can lead to organ damage and failure. The goal of this observational study is to better understand the underlying biological changes that occur in patients with sepsis compared to those who do not have the condition.
We will collect peripheral blood samples from patients diagnosed with sepsis and from non-sepsis control participants. From these samples, we will isolate peripheral blood mononuclear cells (PBMCs) and serum.
We will then analyze these components to measure the activity of specific genes and the levels of key inflammatory factors (cytokines).
The information we gather will help researchers identify molecular and inflammatory markers associated with sepsis. This knowledge is crucial for developing new and more effective methods for diagnosing and treating this critical illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-sepsis patients | – | Diagnostic Test: Gene and Inflammatory Marker Analysis in SepsisSepsis patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of two primary, non-overlapping groups of adult participants recruited from the hospital setting: Sepsis Patient Cohort (Case Group): Adult patients (aged 18 years or older) who are diagnosed with Sepsis based on the Sepsis-3 clinical criteria (or the most current widely accepted clinical definitions) upon admission to the Intensive Care Unit (ICU) or general ward. Non-Sepsis Control Cohort (Control Group): Adult patients (aged 18 years or older) who are admitted to the hospital with non-infectious conditions or healthy volunteers, provided they do not meet the criteria for sepsis or severe infection at the time of enrollment. The enrollment process for both groups will be observational, involving the collection of a single peripheral blood sample for the isolation of peripheral blood mononuclear cells (PBMCs) and serum, as well as collection of relevant clinical data.
Key inclusion criteria (1 listed)
- 1. SOFA score >=2; 2. Aged 18-70 years male and female; 3. Hospitalization.
Key exclusion criteria (1 listed)
- 1. Immune system disease, such as HIV; 2. Disease that possibly affect the function of immune system, such as tumor and chronic viral infection; 3. Patients that treated with massive cortical hormone (>200mg/d) or immunosuppressant; 4. Pregnant or lactation women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene and Inflammatory Marker Analysis in Sepsis1.Sepsis Group: 1. SOFA score >=2; 2. Aged 18-70 years male and female; 3. Hospitalization. 2.Non-sepsis Group: (1) Healthy adults; (2) Aged 18-70 years male and female. | Diagnostic test | Non-sepsis patients |
Primary outcome
TRIM25 in PBMCs
Time frame: From 2021.12 to 2026.06
We will collect peripheral blood mononuclear cells (PBMCs) from both sepsis patients and non-sepsis control patients to compare the expression level of the TRIM25 gene in these cells.
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 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Middle East Study of Infections in Patients With Hematological Malignancies
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Ruijin Hospital at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRIM25 in PBMCs (time frame: From 2021.12 to 2026.06). 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 6 Jan 2026.