NCT03184636

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

June 7, 2017

Last Update Submit

August 12, 2018

Conditions

Keywords

ACLFSOFAZagazig university

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • death of the patient

    24 weeks from first recruiting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Mohamed

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of internal medicine, gastroenterology and hepatology unit

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 12, 2017

Study Start

July 1, 2017

Primary Completion

August 11, 2018

Study Completion

August 11, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations