About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
All patients admitted to the Intensive Care Unit of each year will be enrolled in the study participating center, with a diagnosis of ACLF defined according to the criteria established by the CANONIC study of EASL-CLIF1 that meet the inclusion criteria listed before.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary outcome
The hypothesis underlying the study is to evaluate whether the modulation of bilirubin and other molecules (bile acids and ammonium) and toxic mediators (citokynes), obtainable through the use of extracorporeal purification systems with DM CYTOSORB, can affect the degree of organ failure in affected patients from ACLF.
Secondary outcomes
Secondary outcome
Incidence of clinical complications and adverse events.
Third otucome
Length of stay in Intensive Care Unit.
Fourth outcome
Need for liver transplantation.
Fifth outcome
Survival at 28 days.
Sponsors and contacts
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