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Acute-On-Chronic Liver Failure in Zagazig University Hospitals (ACLF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184636
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
salem youssef mohamed, Zagazig University

Brief Summary:

Rationale:

To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals.

The question of the research:

How much the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals?

The aim of the work:

The aim of the study is to identify the presence of Acute-on-chronic Liver Failure in Zagazig University Hospitals

Objectives:

To estimate the prevalence of Acute-on-chronic Liver Failure in Zagazig University Hospitals.

Subjects and Methods:

I . Technical Design:

  • Site of the study: Gastroenterology and Hepatology Unit- Zagazig University Hospitals
  • Sample size: ''all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD from June 2017 to December 2017 were included in this study''.

II . OPERATIONAL DESIGN:

  • Type of the study: a prospective study.
  • Full medical history - taking.
  • Full clinical examination.
  • Laboratory investigations including Routine laboratory investigation " CBC, Liver functions test, kidney functions test and prothrombin time "

III. Administrative Design:

  • Approvals obtained for performing the study from the official or governmental department.
  • An ethical committee from the faculty of medicine and patients included in the study.

Results:

Collected data will be presented in tables and suitable graphs and analyzed according to standard statistical methods


Condition or disease
Acute-On-Chronic Liver Failure

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ACLF in Zagazig University Hospitals
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : August 11, 2018
Actual Study Completion Date : August 11, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. improvement of the patients score according to SOFA score (AASLD and EASL guidelines) [ Time Frame: 24 weeks from first recruiting ]
    follow up of participants until the patients recover


Secondary Outcome Measures :
  1. death of the patient [ Time Frame: 24 weeks from first recruiting ]
    due to the severity of acute on chronic failure, the death of patients is expected



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD will be included in this study.
Criteria

Inclusion Criteria:

  • all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD will be included in this study.

Exclusion Criteria:

  • no any exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184636


Locations
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Egypt
Salem Mohamed
Zagazig, Sharqia, Egypt, 44519
Sponsors and Collaborators
Zagazig University
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Responsible Party: salem youssef mohamed, assistant professor of internal medicine, gastroenterology and hepatology unit, Zagazig University
ClinicalTrials.gov Identifier: NCT03184636    
Other Study ID Numbers: acute on chronic liver failure
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by salem youssef mohamed, Zagazig University:
ACLF
SOFA
Zagazig university
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute