The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis (SepsisFAT)
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| ClinicalTrials.gov Identifier: NCT06021743 |
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Recruitment Status :
Recruiting
First Posted : September 1, 2023
Last Update Posted : September 7, 2023
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Sponsor:
University Hospital for Infectious Diseases, Croatia
Collaborator:
Croatian Science Foundation
Information provided by (Responsible Party):
University Hospital for Infectious Diseases, Croatia
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Steatosis of Liver Sepsis Immune Response | 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 |
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 Type : | Observational |
| Estimated Enrollment : | 160 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis |
| Actual Study Start Date : | January 1, 2022 |
| Estimated Primary Completion Date : | February 28, 2024 |
| Estimated Study Completion Date : | March 1, 2024 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Sepsis
Patients hospitalized due to the sepsis
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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. Diagnostic Test: 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. Diagnostic Test: Measurement of serum semaphorin concentrations Semaphorin concentration will be measured in patient sera by ELISA. Diagnostic Test: Measurement of inflammatory cytokines A panel of pro- and anti-inflammatory markers will be determined by flow cytometer microsphere-based assay. |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021743
Contacts
| Contact: Nina Vrsaljko, MD | +385914012018 | nvrsaljko@bfm.hr |
Locations
| Croatia | |
| University Hospital for Infectious Diseases Zagreb | Recruiting |
| Zagreb, Croatia, 10000 | |
| Contact: Neven Papic, MD, PhD +38512826222 npapic@bfm.hr | |
| Principal Investigator: Neven Papic, MD, PhD | |
| Sub-Investigator: Branimir Gjurasin, MD | |
| Sub-Investigator: Juraj Krznaric, MD | |
| Sub-Investigator: Nina Vrsaljko, MD | |
| Sub-Investigator: Lara Samadan | |
Sponsors and Collaborators
University Hospital for Infectious Diseases, Croatia
Croatian Science Foundation
Investigators
| Principal Investigator: | Neven Papic, MD, PhD | School of Medicine, University of Zagreb |
| Responsible Party: | University Hospital for Infectious Diseases, Croatia |
| ClinicalTrials.gov Identifier: | NCT06021743 |
| Other Study ID Numbers: |
UHID-08 |
| First Posted: | September 1, 2023 Key Record Dates |
| Last Update Posted: | September 7, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Sepsis Toxemia Liver Diseases Fatty Liver Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Digestive System Diseases |