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

Recruitingn/aAges 18 Years - anyAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06837766 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

3 sites
Azienda Ospedaliero-Universitaria Ospedale Riuniti Umberto I - GM Lancisi - G Salesi, Ancona
Ancona, Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy
Anestesia e Rianimazione 2, Ospedale Niguarda Ca' Granda, Milano
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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