Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease

The concept of acute-on-chronic liver failure (ACLF) was introduced by Jalan and Williams in 2002 to describe the acute deterioration in liver function over 2 to 4 weeks in a patient with well-compensated cirrhosis associated with a precipitating event (hepatotoxic: superimposed hepatitis viral infection, drug-induced liver injury, hepatotoxins, or excessive alcohol consumption; extra hepatic: variceal bleeding or sepsis), leading to severe deterioration in clinical status with jaundice and hepatic encephalopathy and/or HRS. Following this concept, several proposals for the diagnostic criteria of ACLF have been suggested.

Study Overview

• Status: Completed
• Conditions: Acute-On-Chronic Liver Failure

Detailed Description

There may be regional differences in etiology, pathogenesis, and natural course of ACLF, which may in turn influence the overall outcome of this syndrome. So, proper diagnosis of ACLF and its precipitating factors in our locality enable us for proper management of these cases and dealing with these precipitating factors to be avoided later on in patients with liver cirrhosis

Aim of the work:

To identify the pattern of acute on chronic liver cell failure (ACLF) within 28 days including prevalence, percipitating factors, and outcome.

Patients and methods

Type of the study: Prospective hospital based study

Site of the study: Tropical Medicine and Gastroenterology Department, Al-Rajhi University Hospital, Assiut University Hospitals, Assiut, Egypt. Written consent will be obtained from all the participants or their relatives before enrollment.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Al-Rajhi Liver Hospital, Assiut University
  • Assiut, Egypt
    • Al-Rajhi liver hospital ,Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CLD patients with HCV related etiology who will admitted to our hospital with picture of acute decompensation and deterioiration of pre-existing liver condition (defined by the development of ascites, encephalopathy, gastrointestinal haemorrhage and/or bacterial infection) associated with either a single organ failure (single renal failure or other single non-renal organ failure if associated with renal and/or brain dysfunction) or multiple organ failures) to meet the criteria of EASL-CLIF definition .

Description

Inclusion Criteria:

• Adult Patients with HCV related CLD based on clinical, biochemical and imaging evidence., with or without prior decompensation.
• Patients diagnosed to have ACLIF at any grade (1-3)

Exclusion Criteria:

• Acute liver failure without evidence of chronic liver disease.
• Other etiology of chronic liver disease
• Patients diagnosed with no ACLIF No ACLF

• This category includes patients who either:

  • Do not have any organ failure
  • Have a single organ failure that does not involve the kidney with a serum creatinine level of <1.5 mg per dl and no hepatic encephalopathy
  • Have a single brain failure with a serum creatinine level of <1.5 mg per dl
• Patients refuse to participate.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pattern of acute on chronic liver cell failure	evaluation of cases with acute on chronic liver cell failure as number of cases diagnosed with ACLF in this period , the precipitating factor of the condition , the fate of the patient (improving or deterioration or death ) in the 28 days following diagnosis .	march 2018 to march 2019

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohammed Medhat, Al-Arajhy Liver Hospital, Assiut University

Publications and helpful links

General Publications

• Gines P, Quintero E, Arroyo V, Teres J, Bruguera M, Rimola A, Caballeria J, Rodes J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. doi: 10.1002/hep.1840070124.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (ACTUAL): March 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure, Acute; Liver Diseases; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: POACLIFWHCV LC

Drug and device information, study documents

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