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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Liver Disease

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)

• Study Type: Observational
• Enrollment (Estimated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients presented with severe acute liver disease, acute liver failure (ALF) and acute on chronic liver disease (ACLF).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	2 weeks after admission to intensive care unit
Assessment of fluid overload in individuals with ALF admitted to intensive care unit.	Measuring body weight.	2 weeks after admission to intensive care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rates	Assessment of mortality rates in individuals with ALF admitted to intensive care unit.	2 weeks after admission to intensive care unit
Morbidity rates	Assessment of morbidity rates in individuals with ALF admitted to intensive care unit..	2 weeks after admission to intensive care unit

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: Severe ALD in intensive care

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No