acute decompersation of a cirrotic liver - liver failure
Conditions
Interventions
Sponsors
European Foundation for the study of chronic liver failure (EF CLIF)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: The patients admitted/referred to study center with acute decompensation of cirrhosis (ascites, overt encephalopathy, new onset of non-obstructive jaundice, GI-hemorrhage and/or bacterial infections), but without ACLF (as defined according to the CANONIC study) at hospitalization. , Addendum ancillary studie: Protocol 1) 40 patients admitted to the PREDICT study centers in UCL, London, UK, LUMC, Leiden or Alrijne Ziekenhuis, Leiderdorp, The Netherlands, with high-risk CLIF-C * 60 acute decompensation of cirrhosis (ascites, overt encephalopathy, new onset of non-obstructive jaundice, GI-hemorrhage and/or bacterial infections), but without ACLF (as defined according to the CANONIC study) at hospitalization. Protocol 2) A pilot study consisting of 200 patients participating in the PREDICT study (including the 40 patients from protocol 1) will be performed. Centrally randomly selected patients from all participating centers admitted for AD>60 with (n
Exclusion criteria
Exclusion criteria: 1. Patients with acute or subacute liver failure without underlying cirrhosis; 2. Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Milan criteria; 3. Previous liver or other transplantation 4. Admission/referral of more than 72 hours before inclusion , Addendum ancillary studie: No informed consent for participation in the PREDICT study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Assessment of the critical period prior to ACLF development - Characterization of mechanisms responsible for ACLF development - Predictors of clinical course dynamics of ACLF evolution and mortality. - Identification and role of precipitating events for ACLF development. * To elaborate a CLIF-PREDICT score Addendum ancillary study: 1) Endothelial, microvascular and macrovascular function by repeated measurement of microvascular flow using sublingual sidestream-darkfield imaging and forearm blood flow using Doppler-ultrasonography 2) Markers of endothelial cell activation (VWF:Ag, VWFpp, ADMA), systemic vasoconstrictor systems (i.e. copeptin, renin and noradrenaline) and inflammation markers (CRP, leucocytes) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Prospective core ancillary studies to investigate the pathogenesis of ACLF. - Role of chronic systemic inflammation on the development and severity of ACLF - Role of microbiota on the development and severity of ACLF - Role of DILI on the development and severity of ACLF - Role of health trajectory and comorbidities on the development and severity of ACLF * Prospective ancillary studies to investigate the pathogenesis of ACLF. | — |
Countries
Belgium, Denmark, France, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed