SepsisNCT07727265
PyroEVs/PLIN3 Mediate Lipid Droplet-Mitochondrial Coupling in Sepsis Endothelial Injury
An observational study of Sepsis, run by Zhongda Hospital at 1 site in China.
Trial summary
Objective: To investigate the correlation of PyroEVs and PLIN3 with the severity and prognosis of sepsis patients. Participants: Sepsis patients meeting the Sepsis 3.0 diagnostic criteria admitted to the Intensive Care Unit of Zhongda Hospital affiliated with Southeast University, as well as healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ① Study Subjects: Sepsis patients meeting the Sepsis 3.0 diagnostic criteria admitted to the Intensive Care Unit of Zhongda Hospital affiliated with Southeast University, as well as healthy volunteers. ② Inclusion Criteria: 1. Presence of confirmed or suspected infection; 2. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; 3. Signed informed consent. ③ Exclusion Criteria: Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
Who may be able to join
- a. Presence of confirmed or suspected infection; b. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; c. Signed informed consent.
Who cannot join
- Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Fei Fei Peng, PhD. MD., 15950565786, afei0312@163.com
Yang, afei0312@163.com
About this study
Official title: Role and Mechanism of PyroEVs in Regulating Lipid Droplet-Mitochondrial Coupling Via PLIN3 in Sepsis-Induced Vascular Endothelial Cell Injury
Objective: To investigate the correlation of PyroEVs and PLIN3 with the severity and prognosis of sepsis patients.
Participants: Sepsis patients meeting the Sepsis 3.0 diagnostic criteria admitted to the Intensive Care Unit of Zhongda Hospital affiliated with Southeast University, as well as healthy volunteers.
Inclusion Criteria:
- Presence of confirmed or suspected infection;
- Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline;
- Signed informed consent. Exclusion Criteria: Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
Primary outcome: 28-day mortality, SOFA score
- Conditions
- Sepsis
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of pyroptic extracellular vesicles (PyroEVs) in plasma
The concentration of pyroptic extracellular vesicles (PyroEVs) in plasma will be measured using nanoparticle tracking analysis. Results will be reported as particles per milliliter (particles/mL).
Measured: Day 1
Concentration of PLIN3 in plasma
Measured: Day 1
28-day mortality
Measured: 28 days
SOFA score
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Peng, Zhongda Hospital
- Investigators
- Yi Yang, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727265
- Sponsor's protocol ID
- 82372175
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Mechanism of PyroEVs in Regulating Lipid Droplet-Mitochondrial Coupling Via PLIN3 in Sepsis-Induced Vascular Endothelial Cell Injury
- ClinicalTrials.gov ID
- NCT07727265
- Acronym / sponsor ID
- 82372175
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 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.
Objective: To investigate the correlation of PyroEVs and PLIN3 with the severity and prognosis of sepsis patients.
Participants: Sepsis patients meeting the Sepsis 3.0 diagnostic criteria admitted to the Intensive Care Unit of Zhongda Hospital affiliated with Southeast University, as well as healthy volunteers.
Inclusion Criteria:
- Presence of confirmed or suspected infection;
- Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline;
- Signed informed consent. Exclusion Criteria: Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
Primary outcome: 28-day mortality, SOFA score
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ① Study Subjects: Sepsis patients meeting the Sepsis 3.0 diagnostic criteria admitted to the Intensive Care Unit of Zhongda Hospital affiliated with Southeast University, as well as healthy volunteers. ② Inclusion Criteria: 1. Presence of confirmed or suspected infection; 2. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; 3. Signed informed consent. ③ Exclusion Criteria: Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
Key inclusion criteria (1 listed)
- a. Presence of confirmed or suspected infection; b. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; c. Signed informed consent.
Key exclusion criteria (1 listed)
- Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention | Other | Sepsis |
Primary outcome
Concentration of pyroptic extracellular vesicles (PyroEVs) in plasma
Time frame: Day 1
The concentration of pyroptic extracellular vesicles (PyroEVs) in plasma will be measured using nanoparticle tracking analysis. Results will be reported as particles per milliliter (particles/mL).
Concentration of PLIN3 in plasma
Time frame: Day 1
28-day mortality
Time frame: 28 days
SOFA score
Time frame: 28 days
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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Yi Yang principal investigator
Zhongda Hospital
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 Zhongda 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: looking for participants now, as of the sponsor's last update on 27 Jul 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?
Contact Fei Peng, Dr. PhD. (15950565786, afei0312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of pyroptic extracellular vesicles (PyroEVs) in plasma (time frame: Day 1). The study lists 4 primary outcomes in all. 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 27 Jul 2026.