The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis

NCT06021743 | Unknown

• 1 other identifier: UHID-08
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Steatosis of Liver; Sepsis; Immune Response

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Sepsis

Patients hospitalized due to the sepsis

Diagnostic Test: Evaluation of the degree of steatosis; Diagnostic Test: Screening for the components of metabolic syndrome; Diagnostic Test: Measurement of serum semaphorin concentrations; Diagnostic Test: Measurement of inflammatory cytokines

Interventions

Evaluation of the degree of steatosis DIAGNOSTIC_TEST

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.

Sepsis

Screening for the components of metabolic syndrome DIAGNOSTIC_TEST

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.

Sepsis

Measurement of serum semaphorin concentrations DIAGNOSTIC_TEST

Semaphorin concentration will be measured in patient sera by ELISA.

Sepsis

Measurement of inflammatory cytokines DIAGNOSTIC_TEST

A panel of pro- and anti-inflammatory markers will be determined by flow cytometer microsphere-based assay.

Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted at three clinical departments at UHID that meet inclusion criteria will be offered to participate in the study during a 24-month period.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital for Infectious Diseases, Croatia: lead
• Croatian Science Foundation: collaborator

Study Sites (1)

University Hospital for Infectious Diseases Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Fatty Liver; Sepsis

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Neven Papic, MD, PhD

  School of Medicine, University of Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Vrsaljko, MD

CONTACT

+385914012018; nvrsaljko@bfm.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: January 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)