ClinicalTrialsFinder
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

Acute on Chronic Liver Failure (ACLF)

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

Inclusion Criteria4

  • 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 Criteria7

  • 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.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06837766