Study About Hepatic Toxins Kinetic and Evaluation of Organ Damage in Acute on Chronic Liver Failure (ACLF) Patients

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with Acute on Chronic Liver Failure (ACLF), a serious condition where the liver suddenly worsens in patients who already have chronic liver disease. The researchers want to see if a special treatment called extracorporeal purification, using a system known as DM CYTOSORB, can help reduce harmful substances in the blood, like bilirubin, and improve the function of other organs that may be failing. By comparing the health of patients receiving this treatment across several hospitals in Italy, the study aims to find out if it can make a difference in recovery.

To participate in this trial, patients must be at least 18 years old and diagnosed with a severe form of ACLF, which means they have at least two failing organs. Patients with certain conditions, such as advanced liver disease or heart problems, will not be eligible. Those who join the study can expect to undergo regular assessments and treatments as part of their routine care, and they will provide consent to allow their health information to be collected and shared for research purposes. This trial is currently recruiting participants, and it strives to find new ways to help individuals facing the challenges of ACLF.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of acute hepatic decompensation on chronic liver disease with grade ACLF ≥ 2 (diagnosable in the presence of at least two defined organ failures according to the CLIF-C-OF score);
• • hemoabsorbent treatment with Cytosorb;
• • patients aged ≥ 18 years at the time of diagnosis;
• • Informed Consent.
• • Exclusion Criteria
• • patients aged \< 18 years;
• • fulminant liver failure;
• • chronic end-stage liver failure with chronic encephalopathy and/or chronic refractory ascites;
• • acute on chronic hepatic decompensation with grade 0 or 1 ACLF;
• • clinical signs or history of congestive heart failure (NYHA class 3-4 before the acute phase of the disease or documented EF \< 35% or PCWP \> 18 mmHg) or acute coronary syndrome
• • state of immunosuppression (rheumatological and immunological diseases, HIV, immunosuppressive therapy);
• • previous organ transplant.