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

NCT ID: NCT05879445

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-09-01

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)

Conditions

Acute Liver Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdallah Hussein Kamel Ibrahim

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Severe ALD in intensive care

Identifier Type: -

Identifier Source: org_study_id