Liver cirrhosis
Conditions
Brief summary
Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) with death, liver transplantation and TIPS as counting and censoring events
Detailed description
6-months survival, The number of episodes of acute-on-chronic liver failures, Number of organ failures, Time-to-first liver-related clinical outcome, Patients’ quality of life, Time to first hospital admission (in days), Number of hospital admissions, Days spent on hospitalization (in days), Number of intensive care unit admissions, Length of intensive care unit admissions (in days), Number of large volume paracentesis, Analysis of the cost/effectiveness ratio, Health economic evaluation, Changes in serum albumin levels, Number of treatment-related adverse events, Number of treatment-related serious adverse events, Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker, Incidence of refractory ascites, Incidence of variceal bleeding, Incidence of spontaneous bacterial peritonitis, Incidence of infection requiring hospitalization, Incidence of acute kidney injury >= 1B, Incidence of hepatorenal syndrome acute kidney injury, Incidence of overt hepatic encephalopathy, Incidence of liver transplantation, Incidence of TIPS insertion
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of liver-related clinical outcomes (variceal bleeding, ascites, spontaneous bacterial peritonitis, infection requiring hospitalization, acute kidney injury and overt hepatic encephalopathy) with death, liver transplantation and TIPS as counting and censoring events | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-months survival, The number of episodes of acute-on-chronic liver failures, Number of organ failures, Time-to-first liver-related clinical outcome, Patients’ quality of life, Time to first hospital admission (in days), Number of hospital admissions, Days spent on hospitalization (in days), Number of intensive care unit admissions, Length of intensive care unit admissions (in days), Number of large volume paracentesis, Analysis of the cost/effectiveness ratio, Health economic evaluation, Changes in serum albumin levels, Number of treatment-related adverse events, Number of treatment-related serious adverse events, Signatures associated with a poor prognosis as defined by the Microb-Predict biomarker, Incidence of refractory ascites, Incidence of variceal bleeding, Incidence of spontaneous bacterial peritonitis, Incidence of infection requiring hospitalization, Incidence of acute kidney injury >= 1B, Incidence of hepatorenal syndrome acute kidney injury, Incidence of overt hepatic ence | — |
Countries
Belgium, Denmark, Germany, Hungary, Netherlands, Spain