Acute-On-Chronic Liver FailureNCT03456518
Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease
An observational study of Acute-On-Chronic Liver Failure, run by Assiut University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2018to 30 Nov 2019
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 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 .
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Al-Rajhi Liver Hospital, Assiut University
Asyut, 71515
Al-Rajhi liver hospital ,Assiut university
Asyut
About this study
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.
Read the detailed description
There may be regional differences in etiology, pathogenesis, and natural course of ACLF, which may in turn influence the overall outcome of this syndrome. So, proper diagnosis of ACLF and its precipitating factors in our locality enable us for proper management of these cases and dealing with these precipitating factors to be avoided later on in patients with liver cirrhosis
Aim of the work:
To identify the pattern of acute on chronic liver cell failure (ACLF) within 28 days including prevalence, percipitating factors, and outcome.
Patients and methods
Type of the study: Prospective hospital based study
Site of the study: Tropical Medicine and Gastroenterology Department, Al-Rajhi University Hospital, Assiut University Hospitals, Assiut, Egypt. Written consent will be obtained from all the participants or their relatives before enrollment.
- Conditions
- Acute-On-Chronic Liver Failure
- 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.
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 .
Measured: march 2018 to march 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Nov 2018
- Primary completion31 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Khaled, Assiut University
- Investigators
- Mohammed Medhat, Study director, Al-Arajhy Liver Hospital, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456518
- Sponsor's protocol ID
- POACLIFWHCV LC
- Status last verified
- Jan 2020
- First submitted
- 23 Feb 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 3804191
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT03456518
- Acronym / sponsor ID
- POACLIFWHCV LC
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 7 Mar 2018 (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.
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.
Detailed description
There may be regional differences in etiology, pathogenesis, and natural course of ACLF, which may in turn influence the overall outcome of this syndrome. So, proper diagnosis of ACLF and its precipitating factors in our locality enable us for proper management of these cases and dealing with these precipitating factors to be avoided later on in patients with liver cirrhosis
Aim of the work:
To identify the pattern of acute on chronic liver cell failure (ACLF) within 28 days including prevalence, percipitating factors, and outcome.
Patients and methods
Type of the study: Prospective hospital based study
Site of the study: Tropical Medicine and Gastroenterology Department, Al-Rajhi University Hospital, Assiut University Hospitals, Assiut, Egypt. Written consent will be obtained from all the participants or their relatives before enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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 .
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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:
- Patients refuse to participate.
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
pattern of acute on chronic liver cell failure
Time frame: march 2018 to march 2019
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 .
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 23 Jan 2020.
- Background: PubMed 3804191Gines 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.
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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.
Mohammed Medhat study director
Al-Arajhy Liver Hospital, Assiut University
2 sites 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 Assiut University at 2 sites 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 2 inclusion and 8 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 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
pattern of acute on chronic liver cell failure (time frame: march 2018 to march 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456518, which also lists 1 linked publication.
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 23 Jan 2020.