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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03184636
Other study ID # acute on chronic liver failure
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date August 11, 2018

Study information

Verified date August 2018
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date August 11, 2018
Est. primary completion date August 11, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
Egypt Salem Mohamed Zagazig Sharqia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary improvement of the patients score according to SOFA score (AASLD and EASL guidelines) follow up of participants until the patients recover 24 weeks from first recruiting
Secondary death of the patient due to the severity of acute on chronic failure, the death of patients is expected 24 weeks from first recruiting
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