MERTK Signalling in Monocytes/Macrophages in Patients With Liver Disease
NCT ID: NCT04116242
Last Updated: 2024-06-25
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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COMPLETED
277 participants
OBSERVATIONAL
2015-08-27
2024-06-10
Brief Summary
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Detailed Description
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Given the observation that MERTK levels peak on the day of admission with organ failure and decrease in patients surviving the episode of acute-on-chronic liver failure (ACLF), MERTK Inhibition at a time during progression of cirrhosis but before manifestation of acute decompensation with no cirrhosis (AD) or ACLF might prevent infectious complications, decompensation and improve survival in patients with cirrhosis.
This study is to investigate MER receptor tyrosine kinase (MERTK) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, acute-on-chronic liver failure (ACLF)) and in comparison to patients with acute liver failure and to healthy controls.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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cirrhosis of the liver, stadium Child A
sampling of biological material and health related data collection longitudinally in 6-monthly intervals up to 36 months
blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
cirrhosis of the liver, stadium Child B
sampling of biological material and health related data collection longitudinally in 6-monthly intervals up to 36 months
blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
cirrhosis of the liver, stadium Child C
sampling of biological material and health related data collection longitudinally in 6-monthly intervals up to 36 months
blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
cirrhosis of the liver, acutely decompensated
sampling of biological material and health related data collection on days 1 (Baseline), 3, 7, and 14. If acutely decompensated patients re-compensate they will be followed 6-monthly for up to 36 months
blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
acute liver failure
sampling of biological material and health related data collection on days 1 (Baseline), 3, 7, and 14. If acutely decompensated patients re-compensate they will be followed 6-monthly for up to 36 months
blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
healthy controls
sampling of biological material and health related data collection on day 1 (Baseline)
blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Interventions
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blood sampling for research purpose
blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
clinical data collection
clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
Health-related Questionnaires
Health-related Questionnaires (Questionnaire\_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)
Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
Eligibility Criteria
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Inclusion Criteria
* Patients with acute- or acute-on-chronic chronic liver failure
* Controls with no liver disease
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Swiss National Science Foundation
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Christine Bernsmeier, PD Dr. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Basel, Departement Biomedizin, Gastroenterologie und Hepatologie
Locations
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University Hospital Basel, Hepatology Department and Laboratory
Basel, , Switzerland
Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
King's College Hospital, Institute of Liver studies
London, , United Kingdom
St. Mary's Hospital, Imperial College London, Section of Hepatology
London, , United Kingdom
Countries
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Other Identifiers
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EKSG 15/074; me19Bernsmeier2
Identifier Type: -
Identifier Source: org_study_id
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