Actively Recruiting

Age: 18Years +
All Genders
NCT06837766

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-20

40

Participants Needed

3

Research Sites

222 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute hepatic decompensation on chronic liver disease with ACLF grade 2 or higher (at least two organ failures by CLIF-C-OF score)
  • Receiving hemoabsorbent treatment with Cytosorb
  • Age 18 years or older at diagnosis
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Fulminant liver failure
  • Chronic end-stage liver failure with chronic encephalopathy or refractory ascites
  • ACLF grade 0 or 1 acute on chronic hepatic decompensation
  • Clinical signs or history of congestive heart failure (NYHA class 3-4 before acute phase, ejection fraction under 35%, or PCWP over 18 mmHg) or acute coronary syndrome
  • Immunosuppression from rheumatological or immunological diseases, HIV, or immunosuppressive therapy
  • Previous organ transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Azienda Ospedaliero-Universitaria Ospedale Riuniti Umberto I - GM Lancisi - G Salesi, Ancona

Ancona, Ancona, Italy, 60100

Actively Recruiting

2

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

3

Anestesia e Rianimazione 2, Ospedale Niguarda Ca' Granda, Milano

Milan, Milano, Italy, 20162

Actively Recruiting

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Research Team

A

Antonio Siniscalchi, MD

CONTACT

C

Cristiana Laici, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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