Characterization and Pathogenesis of ACLF

Beobachtungsstudie für Die Charakterisierung Der Pathogenese Des Akut-auf-chronischen Leberversagens

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04975490

Acronym

ACLF-I

Enrollment

1000

Registered

2021-07-23

Start date

2020-12-01

Completion date

2025-12-31

Last updated

2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-On-Chronic Liver Failure, Liver Cirrhosis, Portal Hypertension

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Liver cirrhosis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	90 days	number of patients

Countries

Germany

Contacts

Primary ContactJonel Trebicka, MD, PhD

jonel.trebicka@kgu.de+4963014256

Outcome results