Steatosis of LiverSepsisFATNCT06021743
The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis
An observational study of Steatosis of Liver and Sepsis, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatosis of Liver, Sepsis, Immune Response
- What is being tested?
- Evaluation of the degree of steatosis, Screening for the components of metabolic syndrome and Measurement of serum semaphorin concentrations
- How many people
- 160 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2022to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- no consent
- immunosuppression
- malignancies
- immune diseases
- pregnancy
- HIV infection
- presence of chronic liver disease
- consumption of alcohol > 20 g/day
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital for Infectious Diseases Zagreb
Zagreb, 10000
Neven Papic, MD, PhD, +38512826222, npapic@bfm.hr
Neven Papic, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Steatosis of Liver, Sepsis, Immune Response
- Being tested
- Evaluation of the degree of steatosis, Screening for the components of metabolic syndrome, Measurement of serum semaphorin concentrations, Measurement of inflammatory cytokines
- Medical subject headings
- Fatty Liver, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the degree of steatosisDiagnostic 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.
Screening for the components of metabolic syndromeDiagnostic 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.
Measurement of serum semaphorin concentrationsDiagnostic test
Semaphorin concentration will be measured in patient sera by ELISA.
Measurement of inflammatory cytokinesDiagnostic test
A panel of pro- and anti-inflammatory markers will be determined by flow cytometer microsphere-based assay.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Patients hospitalized due to the sepsis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Jan 2022
- Primary completion28 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatosis of LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital for Infectious Diseases, Croatia
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Science Foundation
- Responsible party
- Sponsor
- Investigators
- Neven Papic, MD, PhD, Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021743
- Sponsor's protocol ID
- UHID-08
- Acronym
- SepsisFAT
- Status last verified
- Sep 2023
- First submitted
- 27 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Immune Semaphorins in Steatotic Liver Disease and Sepsis
- ClinicalTrials.gov ID
- NCT06021743
- Acronym / sponsor ID
- SepsisFAT / UHID-08
- Conditions
- Steatosis of Liver, Sepsis, Immune Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital for Infectious Diseases, CroatiaUniversity, hospital or other
- Collaborators
- Croatian Science Foundation
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 cytokinesPatients hospitalized due to the sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- no consent
- immunosuppression
- malignancies
- immune diseases
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the degree of steatosisThe 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 | Sepsis |
| Screening for the components of metabolic syndromeAnthropometric 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 | Sepsis |
| Measurement of serum semaphorin concentrationsSemaphorin concentration will be measured in patient sera by ELISA. | Diagnostic test | Sepsis |
| Measurement of inflammatory cytokinesA panel of pro- and anti-inflammatory markers will be determined by flow cytometer microsphere-based assay. | Diagnostic test | Sepsis |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neven Papic, MD, PhD principal investigator
University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatosis of Liver and Sepsis, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Vrsaljko, MD (+385914012018, nvrsaljko@bfm.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of semaphorins in patients with sepsis and SLD (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.