Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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