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NCT Number: NCT07727265

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. 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).

  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

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

Role and Mechanism of PyroEVs in Regulating Lipid Droplet-Mitochondrial Coupling Via PLIN3 in Sepsis-Induced Vascular Endothelial Cell Injury

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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