NCT03267615: VICIS

VICIS - Vienna Cirrhosis Study

Recruiting now Last updated 25 September 2025

What this trial tests

trial in Liver Cirrhosis in 10,000 participants. Currently enrolling.

Timeline

1 February 2017

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Medical University of Vienna
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	1 February 2017
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across Austria

Conditions studied

• Liver Cirrhosis — all drugs for Liver Cirrhosis →
• Portal Hypertension — all drugs for Portal Hypertension →
• Ascites — all drugs for Ascites →
• Variceal Hemorrhage — all drugs for Variceal Hemorrhage →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 100, any sex, with Liver Cirrhosis or Portal Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank.

Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital.

This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Systemic inflammation increases across distinct stages of advanced chronic liver disease and correlates with decompensation and mortality.
   Costa D, Simbrunner B, Jachs M, Hartl L, et al · · 2021 · cited 159× · PMID 33075344 · DOI 10.1016/j.jhep.2020.10.004
2. Alcohol Abstinence Improves Prognosis Across All Stages of Portal Hypertension in Alcohol-Related Cirrhosis.
   Hofer BS, Simbrunner B, Hartl L, Jachs M, et al · · 2023 · cited 92× · PMID 36481475 · DOI 10.1016/j.cgh.2022.11.033
3. Systemic inflammation is linked to liver fibrogenesis in patients with advanced chronic liver disease.
   Simbrunner B, Villesen IF, Königshofer P, Scheiner B, et al · · 2022 · cited 40× · PMID 35822301 · DOI 10.1111/liv.15365
4. Bacterial translocation occurs early in cirrhosis and triggers a selective inflammatory response.
   Simbrunner B, Caparrós E, Neuwirth T, Schwabl P, et al · · 2023 · cited 37× · PMID 36881247 · DOI 10.1007/s12072-023-10496-y
5. Factor VIII/protein C ratio independently predicts liver-related events but does not indicate a hypercoagulable state in ACLD.
   Scheiner B, Balcar L, Nussbaumer RJ, Weinzierl J, et al · · 2022 · cited 32× · PMID 35066090 · DOI 10.1016/j.jhep.2021.12.038
6. Assessment of portal hypertension severity using machine learning models in patients with compensated cirrhosis.
   Reiniš J, Petrenko O, Simbrunner B, Hofer BS, et al · · 2023 · cited 28× · PMID 36152767 · DOI 10.1016/j.jhep.2022.09.012
7. Non-invasive detection of portal hypertension by enhanced liver fibrosis score in patients with different aetiologies of advanced chronic liver disease.
   Simbrunner B, Marculescu R, Scheiner B, Schwabl P, et al · · 2020 · cited 27× · PMID 32358998 · DOI 10.1111/liv.14498
8. Dysregulated biomarkers of innate and adaptive immunity predict infections and disease progression in cirrhosis.
   Simbrunner B, Hartl L, Jachs M, Bauer DJM, et al · · 2023 · cited 20× · PMID 37035457 · DOI 10.1016/j.jhepr.2023.100712