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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, day 1, day 2, day 3, day 7, day 8, until completion of the study (average 10 days).

Secondary outcomes

1

Secondary outcome

Incidence of clinical complications and adverse events.

Time frame
From admission to intensive care up to 28 days.
2

Third otucome

Length of stay in Intensive Care Unit.

Time frame
From admission to intensive care up to 28 days.
3

Fourth outcome

Need for liver transplantation.

Time frame
From admission to intensive care up to 28 days.
4

Fifth outcome

Survival at 28 days.

Time frame
From admission to intensive care up to 28 days.

Other outcomes

Sponsors and contacts

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