Study About Hepatic Toxins Kinetic and Evaluation of Organ Damage in Acute on Chronic Liver Failure (ACLF) Patients
Recruiting · NCT06837766 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 it is running
3 locations listed.
- 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