Evaluating organ damage in patients with acute on chronic liver failure

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

This study is testing if a special treatment can help improve liver function and reduce organ damage in patients with severe liver failure who are in intensive care.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Academic / other)
• Locations: 3 sites (Ancona, Ancona and 2 other locations)
• Trial ID: NCT06837766 on ClinicalTrials.gov

What this trial studies

This observational multicenter study focuses on patients admitted to intensive care with acute on chronic liver failure (ACLF) of grade 2 or higher. It aims to assess the impact of extracorporeal purification using DM CYTOSORB on the modulation of bilirubin and other toxic substances in these patients. By collecting clinical and laboratory data from multiple Italian intensive care centers, the study seeks to understand how this treatment may influence the degree of organ failure and overall patient outcomes. The study is grounded in the recent definitions and clinical guidelines surrounding ACLF, emphasizing a multidisciplinary approach to patient care.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with grade 2 or higher ACLF and undergoing hemoabsorbent treatment with Cytosorb.

Not a fit: Patients with fulminant liver failure, chronic end-stage liver failure with chronic encephalopathy, or those with ACLF grade 0 or 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with acute on chronic liver failure, potentially reducing organ failure and mortality rates.

How similar studies have performed: While this approach is based on recent definitions and clinical practices, the specific use of DM CYTOSORB in this context is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Ancona, Ancona and 2 other locations

• Azienda Ospedaliero-Universitaria Ospedale Riuniti Umberto I - GM Lancisi - G Salesi, Ancona — Ancona, Ancona, Italy (Recruiting)
• IRCCS Azienda Ospedaliero Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
• Anestesia e Rianimazione 2, Ospedale Niguarda Ca' Granda, Milano — Milan, Milano, Italy (Recruiting)

Study contacts

• Principal investigator: Antonio Siniscalchi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Antonio Siniscalchi, MD

Conditions Acute on Chronic Liver Failure; Acute on Chronic Liver Failure,; Model for End stage Liver Disease; Chronic LIver Failure - Consortium Organ Failure; Renal Replacement Therapy