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RecruitingNCT07727265Updated Jul 27, 2026

PyroEVs/PLIN3 Mediate Lipid Droplet-Mitochondrial Coupling in Sepsis Endothelial Injury

An observational study in Sepsis, sponsored by Zhongda Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Zhongda Hospital · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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. 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

02

Conditions studied

  • Sepsis

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03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 180 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Zhongda Hospital is the lead sponsor of 101 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • a. Presence of confirmed or suspected infection; b. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; c. Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sepsis

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No intervention

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Day 1

  2. Concentration of PLIN3 in plasma

    Time frame: Day 1

  3. 28-day mortality

    Time frame: 28 days

  4. SOFA score

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
  • Zhongda Hospital, Southeast University
    Nanjing, Jiangsu 210009, China
    • Fei Fei Peng, PhD. MD. · Contact · afei0312@163.com · 15950565786
    • Yang · Contact · afei0312@163.com
    • Yi Yang, Dr.PhD. · Principal investigator
    • Fei Peng, Dr.PhD. · Sub investigator
    • Zihan Hu, Dr. · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07727265
Lead sponsor
Zhongda Hospital
Responsible party
Fei Peng (Principal Investigator, Zhongda Hospital) — Principal investigator
First posted
Jul 27, 2026
Start date
Jul 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 27, 2026

Study contacts

Fei Peng, Dr. PhD.
Contact
afei0312@163.com
15950565786
Yi Yang
principal investigator · Zhongda Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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