Acute-On-Chronic Liver FailureNCT06142968
Acute on Chronic Liver Failure in Cirrhotic Patients at Assiut University Hospitals
An observational study of Acute-On-Chronic Liver Failure, run by Assiut University.
Trial summary
ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- laboratory tests
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Oct 2026
- 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 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: all patients with liver cirrhosis
Who may be able to join
- all cirrhotic patients who will be admitted to our intensive care unit in our hospital meeting the criteria of defention of ACLF according to the CANONIC trial and The European Association for the Study of the Liver graded with chronic liver failure organ failure scor ( CLIF-OF )
Who cannot join
- 1- children less than 16 years 2- adult more than 70 years 3- patients with Hepatocellular carcinoma 4- patients known to be Chronic kidney disease
Trial locations and contacts
No sites are listed yet.
DR.Effat Abdl hady El tony, doctor contact
About this study
Official title: Incidence and Outcomes of Acute on Chronic Liver Failure (ACLF) in Cirrhotic Patients at Assiut University Hospitals
ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often precipitated by bacterial infection.
Read the detailed description
Liver cirrhosis is the result of progressive fibrosis in patients with chronic liver disease of any etiology, and is associated with a poor prognosis, once hepatic decompensation starts.
Cirrhosis has two main phases: the compensated phase, where patients maintain preserved liver synthetic function and have no significant extrahepatic organ impairment; this is to be compared with a decompensated phase, where increasing ascites and loss of liver synthetic function, together with presentation with other organ impairment, are common clinical presentations. Renal failure, hepatic encephalopathy (HE), recurrent infections and upper gastrointestinal bleeding from worsening portal hypertension are considered end- stage complications of decompensated cirrhosis. The term acute- on- chronic liver failure (ACLF) is used to describe the clinical syndrome where acute hepatic decompensation leads to organ failures in the setting of liver cirrhosis.
Although there is not a universal agreement about the definition of acute on chronic liver failure (ACLF), there is a wide agreement that ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often precipitated by bacterial infection.
In the CANONIC study, ACLF was defined as 'an acute deterioration of pre- existing chronic liver disease, sometimes related to a clear precipitating event, and associated with increased mortality at 28 days.
The North American consortium for studying liver disease (NACSELD) proposed another definition of ACLF that defines it as 'a condition in patients with underlying chronic liver disease with or without cirrhosis that is associated with mortality within 3 months in the absence of treatment of the underlying liver disease, liver support, or liver transplantation'.
Currently, the term ACLF is still a relatively new entity that has not been very well studied or investigated in our medical research environment. There are no major studies that aimed at looking at the incidence of ACLF in our medical settings.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- laboratory tests
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory testsDiagnostic test
Laboratory tests inform of Complete blood count , liver function tests , kidney function tests abdominal ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
CHILD Pugh score
Child-Pugh A: 5 to 6 points. Child-Pugh B: 7 to 9 points. Child-Pugh C: 10 to 15 points.
Measured: baseline
Secondary outcomes (1)
ACLF score ( acute on chronic liver failure score )
higher scores represent bad outcomes , higher mortality
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionOct 2026 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nardin Nadi Roshdy Saweres, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142968
- Sponsor's protocol ID
- ACLF
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arroyo V, Moreau R, Kamath PS, Jalan R, Gines P, Nevens F, Fernandez J, To U, Garcia-Tsao G, Schnabl B. Acute-on-chronic liver failure in cirrhosis. Nat Rev Dis Primers. 2016 Jun 9;2:16041. doi: 10.1038/nrdp.2016.41.
PubMed 27277335
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcomes of Acute on Chronic Liver Failure (ACLF) in Cirrhotic Patients at Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT06142968
- Acronym / sponsor ID
- ACLF
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Nov 2023 (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.
ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often precipitated by bacterial infection.
Detailed description
Liver cirrhosis is the result of progressive fibrosis in patients with chronic liver disease of any etiology, and is associated with a poor prognosis, once hepatic decompensation starts.
Cirrhosis has two main phases: the compensated phase, where patients maintain preserved liver synthetic function and have no significant extrahepatic organ impairment; this is to be compared with a decompensated phase, where increasing ascites and loss of liver synthetic function, together with presentation with other organ impairment, are common clinical presentations. Renal failure, hepatic encephalopathy (HE), recurrent infections and upper gastrointestinal bleeding from worsening portal hypertension are considered end- stage complications of decompensated cirrhosis. The term acute- on- chronic liver failure (ACLF) is used to describe the clinical syndrome where acute hepatic decompensation leads to organ failures in the setting of liver cirrhosis.
Although there is not a universal agreement about the definition of acute on chronic liver failure (ACLF), there is a wide agreement that ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often precipitated by bacterial infection.
In the CANONIC study, ACLF was defined as 'an acute deterioration of pre- existing chronic liver disease, sometimes related to a clear precipitating event, and associated with increased mortality at 28 days.
The North American consortium for studying liver disease (NACSELD) proposed another definition of ACLF that defines it as 'a condition in patients with underlying chronic liver disease with or without cirrhosis that is associated with mortality within 3 months in the absence of treatment of the underlying liver disease, liver support, or liver transplantation'.
Currently, the term ACLF is still a relatively new entity that has not been very well studied or investigated in our medical research environment. There are no major studies that aimed at looking at the incidence of ACLF in our medical settings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with liver cirrhosis
Key inclusion criteria (1 listed)
- all cirrhotic patients who will be admitted to our intensive care unit in our hospital meeting the criteria of defention of ACLF according to the CANONIC trial and The European Association for the Study of the Liver graded with chronic liver failure organ failure scor ( CLIF-OF )
Key exclusion criteria (1 listed)
- 1- children less than 16 years 2- adult more than 70 years 3- patients with Hepatocellular carcinoma 4- patients known to be Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory testsLaboratory tests inform of Complete blood count , liver function tests , kidney function tests abdominal ultrasound | Diagnostic test | – |
Primary outcome
CHILD Pugh score
Time frame: baseline
Child-Pugh A: 5 to 6 points. Child-Pugh B: 7 to 9 points. Child-Pugh C: 10 to 15 points.
1 secondary outcome
ACLF score ( acute on chronic liver failure score )
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Results publication: PubMed 27277335Arroyo V, Moreau R, Kamath PS, Jalan R, Gines P, Nevens F, Fernandez J, To U, Garcia-Tsao G, Schnabl B. Acute-on-chronic liver failure in cirrhosis. Nat Rev Dis Primers. 2016 Jun 9;2:16041. doi: 10.1038/nrdp.2016.41.
- Related InfoLink provided by the sponsor.
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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.
DR.Effat Abdl hady El tony, doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nardin Nadi Roshdy Saweres, Master (01281129495, lollaz.fabio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHILD Pugh score (time frame: baseline). 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 NCT06142968, 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 22 Nov 2023.