Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Launched by EUROPEAN FOUNDATION FOR STUDY OF CHRONIC LIVER FAILURE · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to improve the care of patients with decompensated cirrhosis, a serious liver condition. Researchers want to test new biomarkers, which are specific molecules in the body that can help predict how well a patient will do after being discharged from the hospital. This study focuses on patients who have recently experienced serious complications related to their liver disease and are expected to recover quickly enough to leave the hospital within 48 hours.

To be eligible for this study, participants must be between 18 and 80 years old and have been admitted to the hospital due to complications from decompensated cirrhosis. The study will not include individuals with certain conditions, such as active cancer (except specific types), severe heart or lung diseases, or those who have had a liver transplant. If eligible, participants will provide written consent and help researchers understand how these new biomarkers might improve health outcomes for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 80 years.
• • 2. Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive- related gastrointestinal bleeding, bacterial infection, or any combination of these), including those who presented ACLF during hospitalization.
• • 3. Recovery from AD and expected to be discharged within the next 48 hours.
• Exclusion Criteria:
• • 1. Admission for planned diagnostic or therapeutic procedures
• • 2. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
• • 3. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
• • 4. HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
• • 5. Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician
• • 6. Previous liver or other organ transplantation
• • 7. Patients with TIPS or other surgical porto-caval shunts
• • 8. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \<20 ml/min according to the MDRD equations
• • 9. Chronic heart failure NYHA class III or IV
• • 10. Pulmonary disease GOLD III or IV
• • 11. Patients with a history of significant extrahepatic disease with life expectancy \<6 months
• • 12. Severe psychiatric disorders
• • 13. Pregnancy and breast-feeding
• • 14. Expected low adherence to study protocol as judged by physician
• • 15. Patients who cannot provide written informed consent or refuse to participate