Liver cirrhosis
Conditions
Brief summary
Time to first unplanned re-hospitalization* or death within 12 months after randomization (composite endpoint). *Exception: expected re-hospitalization for paracentesis in patients with a history of refractory ascites (without any other complication of cirrhosis) during a period of 30 days.
Detailed description
Death (all-cause and liver-related)., Unplanned re-hospitalization., Any Infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus infection, Sars-CoV-2-infection)., Acute hepatic decompensation and ACLF., Upper and lower gastrointestinal bleeding event., Experimental Endpoint: Changes of intestinal microbiota between baseline and day 90.
Interventions
DRUGNexium mups 20 mg magensaftresistente Tabletten
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first unplanned re-hospitalization* or death within 12 months after randomization (composite endpoint). *Exception: expected re-hospitalization for paracentesis in patients with a history of refractory ascites (without any other complication of cirrhosis) during a period of 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Death (all-cause and liver-related)., Unplanned re-hospitalization., Any Infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus infection, Sars-CoV-2-infection)., Acute hepatic decompensation and ACLF., Upper and lower gastrointestinal bleeding event., Experimental Endpoint: Changes of intestinal microbiota between baseline and day 90. | — |
Countries
Germany
Outcome results
None listed