Acute-On-Chronic Liver Failure In Cirrhotic Patients

Acute-On-Chronic Liver Failure In Cirrhotic Patients In Sohag University Hospital

Cirrhosis is a condition characterized by diffuse fibrosis, severe disruption of the intrahepatic arterial and venous flow, portal hypertension and, ultimately, liver cell failure. Traditionally, cirrhosis has been dichotomised in compensated and decompensated, and the transition to decompensated cirrhosis happens when any of the following hallmarks occurs: presence of ascites, variceal haemorrhage and/ or hepatic encephalopathy (HE) . In Egypt, HCV is the main cause of liver cirrhosis followed by HBV

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver

Detailed Description

Cirrhosis is a condition characterized by diffuse fibrosis, severe disruption of the intrahepatic arterial and venous flow, portal hypertension and, ultimately, liver cell failure. Traditionally, cirrhosis has been dichotomised in compensated and decompensated, and the transition to decompensated cirrhosis happens when any of the following hallmarks occurs: presence of ascites, variceal haemorrhage and/ or hepatic encephalopathy (HE). In Egypt, HCV is the main cause of liver cirrhosis followed by HBV. Once cirrhosis transitions from the compensated to the decompensated stage, it is associated with short-term survival (3-5 years) . The concept of acute-on-chronic liver failure (ACLF) has been widely used to study patients who underwent artificial support therapies as a bridge to liver transplantation (LT). In 2009, the Asian Pacific Association for the Study of the Liver (APASL) provided the first consensus on ACLF, defined as "an acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites and/or encephalopathy". In 2014, the definition was further expanded to include 'high 28-day mortality'. Therefore, acute on top of chronic liver failure (ACLF) is defined as a syndrome characterized by acute decompensated cirrhosis associated with failure of various organs and high short term mortality rate; based on CANONIC study which is a large scale prospective study, in which the kidneys were the most common affected organs, followed by liver, coagulation, the brain, circulation and the lungs. ACLF can occur in patients with chronic liver disease without cirrhosis (type A), with compensated cirrhosis (type B), and with decompensated cirrhosis (type C) .In many cases, a precipitating factor linked to the development of ACLF can be identified including alcohol intake, reactivation of HBV or acute hepatitis due to HAV or HEV, bacterial infection or GI hemorrhage. The CLIF-C OF score which consists of numbers and types of organ failures (OFs) including kidneys, liver, coagulation, the brain, circulation, and the lungs is associated with 28-day and 90-day mortality. Moreover, some specific organ dysfunction such as kidney dysfunction and moderate HE, when associated with single OF, was also associated with bad prognosis . On this background, diagnostic criteria of ACLF were established according to the presence, type and number of OFs.

The severity of ACLF was graded into different stages according to the number of OFs on ACLF grade 1, grade 2 and grade 3 and mortality correlates with ACLF severity.

To predict prognosis and mortality more accurately. developed CLIF-C-ACLF score which has a greater prognostic capability than CLIF-C- OF, It consists of the CLIF-C- OF combined with age and WBCs count. Few studies have addressed the patterns of acute on chronic liver failure in Egyptian cirrhotic patients . Therefore, we will conduct our study to shed

• Study Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cirrhotic patients whether compensated or decompensated with an acute decompensation of cirrhosis which is defined by the recent development of ascites, encephalopathy, GI haemorrhage, bacterial infection, or any combination of these

Description

Inclusion Criteria:

• Cirrhotic patients whether compensated or decompensated with an acute decompensation of cirrhosis which is defined by the recent development of ascites, encephalopathy, GI haemorrhage, bacterial infection, or any combination of these

Exclusion Criteria:

• no exclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of 28 day mortality rate in acute on chronic liver failure patients. with acute on top of chronic liver failure	It will be determined by univariate and multivariate analysis.	4 weeks from start point.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triggers of development of ACLF .	Alcohol intake, reactivation of HBV, acute hepatitis, bacterial infection, and GI haemorrhage	4 weeks from start point.
Types and numbers of organ failures in patients with ACLF.	Kidneys, liver, coagulation, the brain, circulation, and the lungs.	4 weeks from start point

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cirrhosis, liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Fibrosis; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Cirrhosis
• Other Study ID Numbers: Soh-Med-21-02-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No