Last updated on April 2018

Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study

Brief description of study

The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).

Detailed Study Description

  1. This International-European, investigator-initiated, multicenter, prospective, observational study will be performed in centers that belong to the European Foundation for the Study of Chronic Liver failure (EF-CLIF)-European Association for Study of the Liver (EASL)-EASL-CLIF Consortium.
  2. The population of patients would include ca. 1,200 cirrhotic patients over a twelve-months period. These patients will be admitted/referred to the study center because of acute decompensation (AD) of cirrhosis (ascites, overt encephalopathy, GI-hemorrhage, new onset of non-obstructive jaundice and/or bacterial infections), without ACLF (as defined according to the Canonic study ) at hospitalization.
  3. After the enrolment visit, the patients will be stratified into two groups: Group 1 patients with high risk of ACLF development (CLIF-C AD score 50) and in Group 2 patients with low risk of ACLF (CLIF-C AD score <50). The whole cohort will be followed for 3 months, while Group 1 will be followed more closely. Development of ACLF is an end-point and in this case a final visit 7-10 days after ACLF development is planned. Data on liver transplantation, mortality and causes of mortality 3 months, 6 months and 12 months will be collected in the whole cohort.
  4. Prospective collection of biological material and performance of ancillary studies investigating predictors for development and pathogenesis of ACLF.

Specific goals of the study:

  • To identify early clinical predictors, biomarkers, mechanisms and precipitating events during the critical period prior to and involved in the development and clinical course of ACLF (with special emphasis to medical trajectory and drug history) in patients admitted/referred to study center with acute decompensation of cirrhosis (ascites, GI-hemorrhage, overt encephalopathy, new onset of non-obstructive jaundice and/or bacterial infections) and the chronological relationship of the events with occurrence and dynamics of ACLF development.
  • To develop a score predicting ACLF development (CLIF-PREDICT score) and assess 28-day, 90-day, 6-month and 1-year all-cause mortality in cirrhotic patients with acute AD, but without ACLF.
  • To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis and pathogenesis of AD and ACLF.

Main endpoints

  • Assessment of the critical period prior to ACLF development
  • Characterization of mechanisms responsible for ACLF development
  • Predictors of clinical course dynamics of ACLF evolution and mortality.
  • Identification and role of precipitating events for ACLF development.
  • To elaborate a CLIF-PREDICT score 2. Secondary endpoints
  • Prospective core ancillary studies to investigate the pathogenesis of ACLF.

Clinical Study Identifier: NCT03056612

Contact Investigators or Research Sites near you

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Rudolph Stauber

Medical University Graz
Graz, Austria
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Heinz Zoller

Medical University of Innsbruck
Innsbruck, Austria
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Thomas Reiberger

Medical University of Vienna
Vienna, Austria
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Sven Franque

University Hospital Antwerp
Antwerp, Belgium
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Thierry Gustot

C.U.B Erasmo
Brussels, Belgium
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Xavier Verhelst

Ghent University Hospital
Ghent, Belgium
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Frederic Nevens

University Hospital Leuven
Leuven, Belgium
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Henning Grønbaeck

Aarhus University Hospital
Aarhus, Denmark
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Flemming Bendtsen

Hvidovre University Hospital
Copenhagen, Denmark
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Roland Amathieu

Hospital Jean Verdier
Bondy, France
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Claire Francoz

Hopital Beaujon
Paris, France
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Faouzi Saliba

Hopital Paul Brousse
Paris, France
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Eric Nguyen-Khac

CHU Amiens-Picardie
Picardie, France
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Christophe Bureau

CHU Toulouse
Toulouse, France
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Christian Trautwein

RTWH Aachen
Aachen, Germany
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Jonel Trebicka

University Hospital Bonn
Bonn, Germany
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Tania Welzel

JW Goethe University Hospital
Frankfurt am Main, Germany
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Alexander Zipprich

University Hospital Halle-Wittenberg
Halle, Germany
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Michael Manns

Hannover Medical School
Hannover, Germany
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Toni Bruns

University Hospital Jena
Jena, Germany
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Cornelius Engelmann

University Hospital Leipzig
Leipzig, Germany
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Marcus-Alexander Wörns

University Hospital Mainz
Mainz, Germany
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Alexander Gerbes

University Hospital Munich LMU
Munich, Germany
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Maria Papp

University of Debrecen
Debrecen, Hungary
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Paolo Caraceni

University of Bologna
Bologna, Italy
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Pietro Gatti

Internal Medicine PO Ostuni
Brindisi, Italy
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Paolo angeli

University Clinic Padova
Padova, Italy
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Manuela Merli

Universita Sapienza
Rome, Italy
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Carlo Alessandria

A.O.U. Torino
Torino, Italy
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Minneke Coenraad

Leiden University Medical Center
Leiden, Netherlands
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Rob de Man

Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands
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Jose Presa

CHTMAD Vila Real
Vila Real, Portugal
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Martin Janicko

Pavol Jozef Sfarik University Kosice/Roosevelt Hospital Bystrica
Kosice, Slovakia
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Pere Gines

Hospital Clinic y Provencial de Barcelona
Barcelona, Spain
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German Soriano

Hospital de Sant Pau
Barcelona, Spain
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Victor Vargas

Hospital Universitari Vall d Hebron
Barcelona, Spain
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Rafael Banares

Hospital General Universitario Gregorio Maranon
Madrid, Spain
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Agustin Albillos

Hospital Ramon y Cajal
Madrid, Spain
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Manuel Romero

Virgen del Rocio
Sevilla, Spain
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Andrea de Gottardi

Bern, Switzerland
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Laura Elkrief

H pitaux Universitaires Geneve
Geneva, Switzerland
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Christine Bernsmeier

Cantonal Hospital St. Gallen
St. Gallen, Switzerland
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Ramazan Idilman

Ankara University Faculty of Medicine
Ankara, Turkey
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Osman Özdogan

Marsara University
Istanbul, Turkey
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Ahmed Elsharkawy

Birmingham University Hospitals
Birmingham, United Kingdom
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Harry Antoniades

Imperial College
London, United Kingdom
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William Bernal

King s College
London, United Kingdom
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Raj Mookerjee

Royal Free Hospital
London, United Kingdom
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Steve Ryder

Nottingham University Hospitals
Nottingham, United Kingdom
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Juan Acevedo

Derriford Hospital, Plymouth Hospitals Trust
Plymouth, United Kingdom
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Thierry Thevenot

CHU Besan on
Besançon, France
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Recruitment Status: Open

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