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Recruiting NCT07727265

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

Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Other No Intervention: Observational Cohort
    No intervention

Primary outcome measures

  • Concentration of pyroptic extracellular vesicles (PyroEVs) in plasma [Time frame: Day 1]
  • Concentration of PLIN3 in plasma [Time frame: Day 1]
  • 28-day mortality [Time frame: 28 days]
  • SOFA score [Time frame: 28 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongda Hospital, Southeast University — Nanjing

Identifiers

NCT: NCT07727265 · 82372175

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗