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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Azienda Ospedaliero-Universitaria Ospedale Riuniti Umberto I - GM Lancisi - G Salesi, Ancona
RECRUITING
Ancona
IRCCS Azienda Ospedaliero Universitaria di Bologna
RECRUITING
Bologna
Anestesia e Rianimazione 2, Ospedale Niguarda Ca' Granda, Milano
RECRUITING
Milan
Contact Information
Primary
Antonio Siniscalchi, MD
antonio.siniscalchi@aosp.bo.it
+393383244708
Backup
Cristiana Laici, MD
cristiana.laici@aosp.bo.it
+393471960155
Time Frame
Start Date: 2021-09-29
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov