Infections Clinical Trial
Official title:
The Interaction of the S100A8/A9 Protein With the Innate Immune System in the Immunopathology of Acute and Chronic Liver Disease
This observational study evaluates the concentration of immune protein S100A8/A9 in different liver failure syndromes, its interaction with the immune system and validity as an immunotherapeutic target to improve survival in patients with advanced cirrhosis and/or acute on chronic liver failure.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: A) Patients with acute or chronic liver disease: 1. Presence of chronic liver disease, or cirrhosis due to any aetiology (latter based upon a histopathological diagnosis or compatible laboratory data and radiological findings) 2. Acute alcoholic hepatitis (definition as per Crabb et al, 2016)35 3. Acute liver failure due to any aetiology 4. Acute-on-chronic liver failure (defined as per EASL-CLIF definition)17 B) Patients undergoing diagnostic or therapeutic abdominal paracentesis Patients with acute or chronic liver disease of any aetiology undergoing clinically-indicated paracentesis for ascites C) Patients undergoing broncho-alveolar lavage 1. Intubated patients with liver disease in intensive care 2. Undergoing a bronchoscopy or a non-directed broncho-alveolar lavage as part of their routine clinical care D) Patients with acute or chronic liver disease undergoing liver biopsy (percutaneous or transjugular) as routine part of their clinical care E) Patients with portal hypertension (cirrhotic or non-cirrhotic) undergoing transjugular intrahepatic shunt (TIPSS) placement as part of their routine care F) Patients with acute or chronic liver disease undergoing orthoptic liver transplantation G) Patients undergoing surgical liver resection or hepatectomy for liver-related diseases Control groups: A) Patients with ascites without chronic liver disease: 1. Absence of cirrhosis based on clinical, radiological or histopathological features, including patients with non-cirrhotic portal hypertension, cardiac ascites (ascites due to heart failure) or patients with chronic kidney disease undergoing continuous ambulatory peritoneal dialysis (CAPD) 2. Presence of clinically significant ascites 3. Undergoing diagnostic or therapeutic paracentesis B) Patients with sepsis without acute or chronic liver disease C) Patients with haemochromatosis without liver disease or end-organ damage who undergo regular venesection D) Healthy subjects Exclusion Criteria: Age under 18 or over 80 Evidence of disseminated malignancy (isolated cancers including hepatocellular carcinoma are not an exclusion criteria) Patients with known immunodeficiency syndromes (e.g. HIV infection) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Arjuna Singanayagam | London Borough Of Wandsworth | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London | King's College Hospital NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of plasma S100A8/A9 | The study will evaluate whether S100A8/A9 concentration can be used to predict clinical outcomes, such as mortality, the development of infection and/or organ failure. In the laboratory, it will evaluate the effect S100A8/A9 has on immune functional readouts including phagocytosis, oxidative burst and cytokine production, all of which are required for an effect immune response. Similarly, by blocking its action, the study will identify whether this is a potential immunotherapeutic strategy to improve the outcome of patients with high concentrations of the protein. | 1 years | |
Secondary | Mortality | 28-, 90-day and 1 year mortality and its relationship to baseline and serial S100A8/A9 concentration | 1 years | |
Secondary | Development of infection | Incidence of infection in patients with liver disease and its relationship to baseline or dynamic S100A8/A9 concentration | 1 years |
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