Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-09-28
2024-09-01
Brief Summary
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Detailed Description
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A danger signal reported in other inflammatory conditions called S100A8/A9 (calprotectin) is known to activate the immune system by production of pro-inflammatory cytokines but has also been observed to promote the development immunosuppressive signals (e.g. IL-10 and MDSCs).
In an attempt to explain this paradox in liver disease, this study proposes to identify at the cellular and molecular level, the triggers for S100A8/A9 production, how it varies with time in stable patients and those that have acute deteriorations including the development of organ failure, and its interaction with innate immune cells in the circulation and at tissue level.
By studying this, the Investigators hope to be able to identify immunotherapeutic targets and understand whether potential immunotherapy could be applied locally or systemically. The Investigators' observations in this study could provide the basis for the future development of clinical immunomodulating agents, which may ameliorate immunopathology, reduce susceptibility to infection and could reduce mortality in critically ill patients with liver disease. Findings in this study may also have more generalizable impact especially with the recent recognition in the COVID-19 pandemic that immunomodulatory therapies may improve the clinical outcomes of inflammatory phenotypes in virus-induced severe sepsis.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
3. Acute liver failure due to any aetiology
4. Acute-on-chronic liver failure
No interventions assigned to this group
Patients undergoing diagnostic or therapeutic abdominal paracentesis
Patients with acute or chronic liver disease of any aetiology undergoing clinically-indicated paracentesis for ascites
No interventions assigned to this group
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
No interventions assigned to this group
Patients with acute or chronic liver disease undergoing liver biopsy
No interventions assigned to this group
Patients with undergoing transjugular intrahepatic shunt (TIPSS) placement
No interventions assigned to this group
Patients with acute or chronic liver disease undergoing orthoptic liver transplantation
No interventions assigned to this group
Patients undergoing surgical liver resection or hepatectomy for liver-related diseases
No interventions assigned to this group
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
No interventions assigned to this group
Patients with sepsis without acute or chronic liver disease
No interventions assigned to this group
Patients with haemochromatosis who undergo regular venesection
No interventions assigned to this group
Healthy subjects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Years
80 Years
ALL
Yes
Sponsors
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King's College Hospital NHS Trust
OTHER
St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Arjuna Singanayagam, MBBS; PhD
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Locations
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Arjuna Singanayagam
Wandsworth, London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Arjuna Singanayagam, MBBS; PhD
Role: primary
Other Identifiers
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285573
Identifier Type: OTHER
Identifier Source: secondary_id
2021.0073
Identifier Type: -
Identifier Source: org_study_id