Acute-On-Chronic Liver FailureACLFNCT03184636
Acute-On-Chronic Liver Failure in Zagazig University Hospitals
An observational study of Acute-On-Chronic Liver Failure, run by Zagazig University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 11 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD will be included in this study.
Who cannot join
- no any exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACLF in Zagazig University Hospitals
Rationale:
To identify the prevalence of Acute-on-chronic liver failure in Zagazig University Hospitals.
Read more
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
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- ACLF, SOFA, Zagazig university
- Medical subject headings
- Acute-On-Chronic Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of the patients score according to SOFA score (AASLD and EASL guidelines)
follow up of participants until the patients recover
Measured: 24 weeks from first recruiting
Secondary outcomes (1)
death of the patient
due to the severity of acute on chronic failure, the death of patients is expected
Measured: 24 weeks from first recruiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Jul 2017
- Primary completion11 Aug 2018
- Study completion11 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, salem youssef mohamed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184636
- Sponsor's protocol ID
- acute on chronic liver failure
- Acronym
- ACLF
- Status last verified
- Aug 2018
- First submitted
- 7 Jun 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACLF in Zagazig University Hospitals
- ClinicalTrials.gov ID
- NCT03184636
- Acronym / sponsor ID
- ACLF / acute on chronic liver failure
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- ACLF, SOFA, Zagazig university
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 11 Aug 2018 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients admitted to Gastroenterology and Hepatology Unit with the criteria of ACLF according to EASL-AASLD will be included in this study.
Key exclusion criteria (1 listed)
- no any exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
death of the patient
Time frame: 24 weeks from first recruiting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of the patients score according to SOFA score (AASLD and EASL guidelines) (time frame: 24 weeks from first recruiting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.