Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease
1 other identifier
observational
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedJanuary 23, 2020
January 1, 2020
12 months
February 23, 2018
January 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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 .
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Al-Rajhi Liver Hospital, Assiut University
Asyut, 71515, Egypt
Al-Rajhi liver hospital ,Assiut university
Asyut, Egypt
Related Publications (1)
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.
PMID: 3804191BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammed Medhat
Al-Arajhy Liver Hospital, Assiut University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 7, 2018
Study Start
November 1, 2018
Primary Completion
October 31, 2019
Study Completion
November 30, 2019
Last Updated
January 23, 2020
Record last verified: 2020-01