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

NCT07727265 | Recruiting

• 1 other identifier: 82372175
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 1.Presence of confirmed or suspected infection;
2. 2.Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline;
3. 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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (4)

• 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).

  Day 1

• Concentration of PLIN3 in plasma

  Day 1

• 28-day mortality

  28 days

• SOFA score

  28 days

Study Arms (1)

Sepsis

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

Sepsis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Yang

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Peng, Dr. PhD.

CONTACT

15950565786; afei0312@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)