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Causes, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units

Causes, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05879445
Enrollment
200
Registered
2023-05-30
Start date
2023-06-20
Completion date
2024-09-01
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Liver Disease

Brief 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. 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: 1. To evaluate cases of (ALF) and (ACLF) according to guidelines. 2. To determine most likely causes of disease in a patient of each age. 3. To determine complications of disease. 4. Assesment of mortality and morbidity rates. 5. 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). 1. Inclusion criteria: 1. reduced conscious state 2. Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal 3. Coagulopathy 4. Multiorgan failure 2. Exclusion criteria: Patients with these criteria will be excluded: 1. Patients with known cardiac cirrhosis. 2. Patients with known pre-existing renal disease * Study tools All patients will be subjected to: 1. Thorough history taking (History of previous renal disease, severe co-morbidity, malignancy, …). 2. Thorough clinical examination 1. Vital signs. 2. General examination. 3. Systemic examination: * Chest examination. * Cardiac examination. * Abdominal examination. * Neurological examination. 3. Imaging 1. Abdominal ultrasound with especial comment on kidneys and intra-abdominal fluid. 2. Chest x-ray 3. Echocardiography 4. Laboratory investigations 1. 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. 2. Serum creatinine: Before and after end of treatment 3. Urine analysis: Before and after end of treatment 4. Albumin creatinine ratio: Before and after end of treatment 5. Measuring body weight Before and after end of treatment 6. Special scores (CLIF-SOFA /CLIF-C OFs /DF /ABIC /GAHS /MELD /MELD-Na /CHILD)

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. reduced conscious state 2. Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal 3. Coagulopathy 4. Multiorgan failure

Exclusion criteria

1. Patients with known cardiac cirrhosis. 2. Patients with known pre-existing renal disease

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Liver function in individuals with ALF admitted to intensive care unit.2 weeks after admission to intensive care unitMeasuring 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.2 weeks after admission to intensive care unitMeasuring serum creatinine level
Assessment of fluid overload in individuals with ALF admitted to intensive care unit.2 weeks after admission to intensive care unitMeasuring body weight.

Secondary

MeasureTime frameDescription
Mortality rates2 weeks after admission to intensive care unitAssessment of mortality rates in individuals with ALF admitted to intensive care unit.
Morbidity rates2 weeks after admission to intensive care unitAssessment of morbidity rates in individuals with ALF admitted to intensive care unit..

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026