RecruitingNCT06837766

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

40 participants

Start Date

Sep 29, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Spontaneous Observational Prospective Multicenter study of all patients admitted to Intensive Care with a diagnosis of Acute on Chronic Liver Failure (ACLF) of grade ≥ 2 for which the use of the system will be authorized extracorporeal purification with DM CYTOSORB. The hypothesis underlying the study is to evaluate whether the modulation of bilirubin and other toxic molecules and mediators, obtainable through the use of systems extracorporeal purification (specifically DM CYTOSORB), may have an impacton the degree of organ failure in patients with ACLF. The study proposes the compilation of a structured and shared data collection with other Italian Intensive Care Centers which include patients suffering from ACLF (multicenter study) of clinical and laboratory parameters, which are part of normal clinical practice.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how toxins build up in the blood during acute-on-chronic liver failure (ACLF) — a sudden severe worsening of chronic liver disease — and whether a blood-purification device called CytoSorb can remove these toxins and reduce organ damage. **You may be eligible if...** - You are 18 or older - You have been diagnosed with acute decompensation of chronic liver disease with at least grade 2 ACLF (meaning at least two organs are failing) - You are receiving or are planned to receive CytoSorb blood-purification treatment - You are able to give informed consent **You may NOT be eligible if...** - You are under 18 - You have sudden (fulminant) liver failure without underlying chronic disease - You have end-stage liver disease with chronic complications like ongoing confusion (encephalopathy) or persistent fluid buildup (refractory ascites) - You have serious pre-existing heart failure or had a recent heart attack - You are immunosuppressed due to a rheumatological or autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Azienda Ospedaliero-Universitaria Ospedale Riuniti Umberto I - GM Lancisi - G Salesi, Ancona

Ancona, Ancona, Italy

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Bologna, Italy

Anestesia e Rianimazione 2, Ospedale Niguarda Ca' Granda, Milano

Milan, Milano, Italy

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NCT06837766


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