Acute Liver DiseaseNCT05879445
Causes, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units
An observational study of Acute Liver Disease, run by Assiut University.
Trial summary
Acute liver failure (ALF) is a potentially fatal complication of severe hepatic illness resulting from various causes. In a clinical setting, severe hepatic injury is usually recognized by the appearance of jaundice, encephalopathy and coagulopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Liver Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 1 Sep 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presented with severe acute liver disease, acute liver failure (ALF) and acute on chronic liver disease (ACLF).
Who may be able to join
- reduced conscious state
- Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal
- Coagulopathy
- Multiorgan failure
Who cannot join
- Patients with known cardiac cirrhosis.
- Patients with known pre-existing renal disease
About this study
Acute liver failure (ALF) is a potentially fatal complication of severe hepatic illness resulting from various causes. In a clinical setting, severe hepatic injury is usually recognized by the appearance of jaundice, encephalopathy and coagulopathy.
The term acute liver failure (ALF) is frequently applied as a generic expression to describe patients presenting with or developing an acute episode of liver dysfunction.
Read more
Cerebral edema is very common in patients with acute liver failure and encephalopathy.
Acute liver failure (ALF) has Less common aetiologies include viral hepatitis, drug-induced liver injury, pregnancy-induced liver failure and autoimmune hepatitis.
Survival for patients with ALF has steadily improved over the last few decades. Acute liver failure (ALF) is defined as sever acute liver injury with encephalopathy and impairment of synthetic function (INR ˃1.5) in a patient without pre-existing cirrhosis or liver disease.
Acute liver failure (ALF) and acute on chronic liver Failure (ACLF) are conditions frequently encountered in the ICU and are associated with high mortality.
Read the detailed description
The main objectives of this observational study are:
- To evaluate cases of (ALF) and (ACLF) according to guidelines.
- To determine most likely causes of disease in a patient of each age.
- To determine complications of disease.
- Assesment of mortality and morbidity rates.
- Assessment of in-hospital and six month follow up outcomes according to guidelines.
Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whichever feasible and possible.
All patients presented with severe acute liver disease, acute liver failure (ALF) and acute on chronic liver disease (ACLF).
- Inclusion criteria:
- reduced conscious state
- Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal
- Coagulopathy
- Multiorgan failure
- Exclusion criteria:
Patients with these criteria will be excluded:
- Patients with known cardiac cirrhosis.
- Patients with known pre-existing renal disease
- Study tools
All patients will be subjected to:
- Thorough history taking (History of previous renal disease, severe co-morbidity, malignancy, …).
- Thorough clinical examination
- Vital signs.
- General examination.
- Systemic examination:
- Chest examination.
- Cardiac examination.
- Abdominal examination.
- Neurological examination.
- Imaging
- Abdominal ultrasound with especial comment on kidneys and intra-abdominal fluid.
- Chest x-ray
- Echocardiography
- Laboratory investigations
- Liver function tests: alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), serum bilirubin, prothrombin time (PT) and albumin. Before and after end of treatment.
- Serum creatinine: Before and after end of treatment
- Urine analysis: Before and after end of treatment
- Albumin creatinine ratio: Before and after end of treatment
- Measuring body weight Before and after end of treatment
- Special scores (CLIF-SOFA /CLIF-C OFs /DF /ABIC /GAHS /MELD /MELD-Na /CHILD)
- Conditions
- Acute Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Liver function in individuals with ALF admitted to intensive care unit.
Measuring serum alanine transaminase (ALT) level, serum aspartate transaminase (AST) level, serum alkaline phosphatase (ALP) level, serum gamma-glutamyl transferase (GGT) level.
Measured: 2 weeks after admission to intensive care unit
Assessment of kidney function in individuals with ALF admitted to intensive care unit.
Measuring serum creatinine level
Measured: 2 weeks after admission to intensive care unit
Assessment of fluid overload in individuals with ALF admitted to intensive care unit.
Measuring body weight.
Measured: 2 weeks after admission to intensive care unit
Secondary outcomes (2)
Mortality rates
Assessment of mortality rates in individuals with ALF admitted to intensive care unit.
Measured: 2 weeks after admission to intensive care unit
Morbidity rates
Assessment of morbidity rates in individuals with ALF admitted to intensive care unit..
Measured: 2 weeks after admission to intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start20 Jun 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver DiseaseStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Hussein Kamel Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879445
- Sponsor's protocol ID
- Severe ALD in intensive care
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units
- ClinicalTrials.gov ID
- NCT05879445
- Acronym / sponsor ID
- Severe ALD in intensive care
- Conditions
- Acute Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 May 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.
Acute liver failure (ALF) is a potentially fatal complication of severe hepatic illness resulting from various causes. In a clinical setting, severe hepatic injury is usually recognized by the appearance of jaundice, encephalopathy and coagulopathy.
The term acute liver failure (ALF) is frequently applied as a generic expression to describe patients presenting with or developing an acute episode of liver dysfunction.
Cerebral edema is very common in patients with acute liver failure and encephalopathy.
Acute liver failure (ALF) has Less common aetiologies include viral hepatitis, drug-induced liver injury, pregnancy-induced liver failure and autoimmune hepatitis.
Survival for patients with ALF has steadily improved over the last few decades. Acute liver failure (ALF) is defined as sever acute liver injury with encephalopathy and impairment of synthetic function (INR ˃1.5) in a patient without pre-existing cirrhosis or liver disease.
Acute liver failure (ALF) and acute on chronic liver Failure (ACLF) are conditions frequently encountered in the ICU and are associated with high mortality.
Detailed description
The main objectives of this observational study are:
- To evaluate cases of (ALF) and (ACLF) according to guidelines.
- To determine most likely causes of disease in a patient of each age.
- To determine complications of disease.
- Assesment of mortality and morbidity rates.
- Assessment of in-hospital and six month follow up outcomes according to guidelines.
Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whichever feasible and possible.
All patients presented with severe acute liver disease, acute liver failure (ALF) and acute on chronic liver disease (ACLF).
- Inclusion criteria:
- reduced conscious state
- Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal
- Coagulopathy
- Multiorgan failure
- Exclusion criteria:
Patients with these criteria will be excluded:
- Patients with known cardiac cirrhosis.
- Patients with known pre-existing renal disease
- Study tools
All patients will be subjected to:
- Thorough history taking (History of previous renal disease, severe co-morbidity, malignancy, …).
- Thorough clinical examination
- Vital signs.
- General examination.
- Systemic examination:
- Chest examination.
- Cardiac examination.
- Abdominal examination.
- Neurological examination.
- Imaging
- Abdominal ultrasound with especial comment on kidneys and intra-abdominal fluid.
- Chest x-ray
- Echocardiography
- Laboratory investigations
- Liver function tests: alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), serum bilirubin, prothrombin time (PT) and albumin. Before and after end of treatment.
- Serum creatinine: Before and after end of treatment
- Urine analysis: Before and after end of treatment
- Albumin creatinine ratio: Before and after end of treatment
- Measuring body weight Before and after end of treatment
- Special scores (CLIF-SOFA /CLIF-C OFs /DF /ABIC /GAHS /MELD /MELD-Na /CHILD)
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presented with severe acute liver disease, acute liver failure (ALF) and acute on chronic liver disease (ACLF).
Key inclusion criteria (4 listed)
- reduced conscious state
- Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal
- Coagulopathy
- Multiorgan failure
Key exclusion criteria (2 listed)
- Patients with known cardiac cirrhosis.
- Patients with known pre-existing renal disease
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
Assessment of Liver function in individuals with ALF admitted to intensive care unit.
Time frame: 2 weeks after admission to intensive care unit
Measuring serum alanine transaminase (ALT) level, serum aspartate transaminase (AST) level, serum alkaline phosphatase (ALP) level, serum gamma-glutamyl transferase (GGT) level.
Assessment of kidney function in individuals with ALF admitted to intensive care unit.
Time frame: 2 weeks after admission to intensive care unit
Measuring serum creatinine level
Assessment of fluid overload in individuals with ALF admitted to intensive care unit.
Time frame: 2 weeks after admission to intensive care unit
Measuring body weight.
2 secondary outcomes
Mortality rates
Time frame: 2 weeks after admission to intensive care unit
Morbidity rates
Time frame: 2 weeks after admission to intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Disease, 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 4 inclusion and 2 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 30 May 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?
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?
Assessment of Liver function in individuals with ALF admitted to intensive care unit. (time frame: 2 weeks after admission to intensive care unit). The study lists 3 primary outcomes in all. 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 30 May 2023.