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

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456518
• Other study ID #: POACLIFWHCV LC
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2019
• Est. primary completion date: October 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Diseases
• Liver Failure

Locations

Country	Name	City	State
Egypt	Al-Rajhi liver hospital ,Assiut university	Assiut
Egypt	Al-Rajhi Liver Hospital, Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ginés P, Quintero E, Arroyo V, Terés J, Bruguera M, Rimola A, Caballería J, Rodés J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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