The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Detection of semaphorins in patients with sepsis and SLD
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •no consent
- •immunosuppression
- •malignancies
- •immune diseases
- •pregnancy
- •HIV infection
- •presence of chronic liver disease
- •consumption of alcohol > 20 g/day
Outcomes
Primary Outcomes
Detection of semaphorins in patients with sepsis and SLD
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported