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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06021743
Other study ID # UHID-08
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date March 1, 2024

Study information

Verified date September 2023
Source University Hospital for Infectious Diseases, Croatia
Contact Nina Vrsaljko, MD
Phone +385914012018
Email nvrsaljko@bfm.hr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date March 1, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 2 or more SIRS (Systemic Inflammatory Response Syndrome) criteria (1. Hyperthermia >38.3°C or Hypothermia <36°C; 2. Tachycardia >90 bpm; 3. Tachypnea >20 bpm; 3. 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

Study Design


Intervention

Diagnostic Test:
Evaluation of the degree of steatosis
The degree of steatosis will be estimated using the ultrasound and a method for grading steatosis will be measuring the degree of ultrasound attenuation by hepatic fat using a process based on simultaneous transient elastography (TE) which measures the degree of steatosis.
Screening for the components of metabolic syndrome
Anthropometric measures including height, weight, waist circumference and hip circumference will be measured in all patients. Results of the routine laboratory tests as part of the standard diagnostic procedure will be collected: CRP, leukocyte count, ratio neutrophils and lymphocytes, hemoglobin, platelet count, urea, creatinine, bilirubin, AST, ALT, GGT, ALP, albumins, fasting glucose.
Measurement of serum semaphorin concentrations
Semaphorin concentration will be measured in patient sera by ELISA.
Measurement of inflammatory cytokines
A panel of pro- and anti-inflammatory markers will be determined by flow cytometer microsphere-based assay.

Locations

Country Name City State
Croatia University Hospital for Infectious Diseases Zagreb Zagreb

Sponsors (2)

Lead Sponsor Collaborator
University Hospital for Infectious Diseases, Croatia Croatian Science Foundation

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of semaphorins in patients with sepsis and SLD Measurement of semaphorins concentration in serum of patients with SLD and sepsis by enzyme-linked immunosorbent assay (ELISA) 24 months
Primary Impact of SLD on sepsis outcomes Analysis of the impact of SLD and steatosis grade (grade 1 - mild steatosis, 2 - moderate, 3 - severe steatosis) on sepsis complications and outcomes. 24 months
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