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临床试验/NCT06021743
NCT06021743招募中不适用

The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis

University Hospital for Infectious Diseases, Croatia1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年1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
160
试验地点
1
主要终点
Detection of semaphorins in patients with sepsis and SLD

研究概览

简要总结

The impact of the complex liver immunological network on sepsis outcome is largely unknown. Steatotic liver disease (SLD) is the most common chronic liver disease with prevalence of 25% in European countries. The question remains whether patients with SLD are more prone to bacterial infections and what is the impact of persistent liver inflammation to the systemic response to infection, sepsis course and outcomes. Semaphorins are a large family of secreted and membrane-bound biological response modifiers present in many organ systems that are associated with SLD and development of fibrosis, but also might regulate systemic immune responses in sepsis. This study will investigate the association of semaphorins with sepsis outcomes in patients with SLD.

详细描述

The liver, with its ability to produce acute phase proteins, complement and cytokines, plays a central role in regulating inflammation. A balanced pro- and anti-inflammatory liver response results in bacterial clearance and resolution of inflammation. Steatotic liver disease (SLD) is the most common chronic liver disease associated with systemic changes in immune response. Although there are numerous immunological links between sepsis and SLD, there is a significant gap in knowledge regarding the role of SLD in sepsis. Semaphorins were recently recognized as one of the key regulators of immune responses; while some suppress immune cells activation, proliferation and production of inflammatory cytokines, others stimulate immune responses. Semaphorins were recently shown to be associated with pathogenesis of viral hepatitis, SLD and progression of fibrosis. However, their role in sepsis is unknown. The hypothesis of this project is that semaphorins are regulators of inflammation in patients with SLD that have impact on sepsis outcome.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 2 or more SIRS (Systemic Inflammatory Response Syndrome) criteria (
  • Hyperthermia >38.3°C or Hypothermia <36°C;
  • Tachycardia >90 bpm;
  • Tachypnea >20 bpm;
  • Leukocytosis (>12,000 μL-1) or Leukopenia (<4,000 μL-1))
  • clinical suspicion of sepsis
  • enrolled within 24 hours of hospital admission

排除标准

  • no consent
  • immunosuppression
  • malignancies
  • immune diseases
  • pregnancy
  • HIV infection
  • presence of chronic liver disease
  • consumption of alcohol > 20 g/day

结局指标

主要结局

Detection of semaphorins in patients with sepsis and SLD

时间窗: 24 months

Measurement of semaphorins concentration in serum of patients with SLD and sepsis by enzyme-linked immunosorbent assay (ELISA)

Impact of SLD on sepsis outcomes

时间窗: 24 months

Analysis of the impact of SLD and steatosis grade (grade 1 - mild steatosis, 2 - moderate, 3 - severe steatosis) on sepsis complications and outcomes.

次要结局

未报告次要终点

研究者

发起方
University Hospital for Infectious Diseases, Croatia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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