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临床试验/NCT07727265
NCT07727265招募中不适用

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

Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
Concentration of pyroptic extracellular vesicles (PyroEVs) in plasma

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Concentration of pyroptic extracellular vesicles (PyroEVs) in plasma

时间窗: 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).

Concentration of PLIN3 in plasma

时间窗: Day 1

28-day mortality

时间窗: 28 days

SOFA score

时间窗: 28 days

次要结局

未报告次要终点

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fei Peng

Principal Investigator

Zhongda Hospital

研究点 (1)

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