Characterization and Pathogenesis of ACLF (ACLF-I)

Johann Wolfgang Goethe University Hospital

Status: Enrolling

Conditions: Acute-On-Chronic Liver Failure; Portal Hypertension; Liver Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT04975490

ACLF-Initiative

Details and patient eligibility

About

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups.

1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis
2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets
3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Liver cirrhosis

Exclusion criteria

• extrahepatic and metastatic malignancy,
• refusal for participation
• decision of attending phycisian

Trial design

1,000 participants in 3 patient groups

SAPIENT = Sepsis ACLF patients

PROACT = Portal mediators as ACLF Targets

ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts