PyroEVs/PLIN3 Mediate Lipid Droplet-Mitochondrial Coupling in Sepsis Endothelial Injury
ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhongda Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
a. Presence of confirmed or suspected infection; b. Sequential Organ Failure Assessment (SOFA) score increase ≥ 2 points from baseline; c. Signed informed consent.
Disqualifiers
Age < 18 or > 80 years, pregnancy, cancer patients, and individuals with diseases potentially complicated by vascular endothelial cell injury.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Sepsis1 intervention
Trial outcomes
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 12
Concentration of PLIN3 in plasma
Time frame
Day 13
28-day mortality
Time frame
28 days4
SOFA score
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov