Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05879445
Collaborator
(none)
200
Enrollment
14.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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:

    2. reduced conscious state

    3. Jaundice with abnormal liver function tests, especially elevations in amino acid transferase levels more than 25 times the upper limit of normal

    4. Coagulopathy

    5. Multiorgan failure

    6. 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

    3. Vital signs.

    4. General examination.

    5. Systemic examination:

    • Chest examination.

    • Cardiac examination.

    • Abdominal examination.

    • Neurological examination.

    1. Imaging

    2. Abdominal ultrasound with especial comment on kidneys and intra-abdominal fluid.

    3. Chest x-ray

    4. Echocardiography

    5. Laboratory investigations

    6. 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.

    1. Serum creatinine:

    Before and after end of treatment

    1. Urine analysis:

    Before and after end of treatment

    1. Albumin creatinine ratio:

    Before and after end of treatment

    1. Measuring body weight Before and after end of treatment

    2. Special scores (CLIF-SOFA /CLIF-C OFs /DF /ABIC /GAHS /MELD /MELD-Na /CHILD)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Causes, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units
    Anticipated Study Start Date :
    Jun 20, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of Liver function in individuals with ALF admitted to intensive care unit. [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.

    2. Assessment of kidney function in individuals with ALF admitted to intensive care unit. [2 weeks after admission to intensive care unit]

      Measuring serum creatinine level

    3. Assessment of fluid overload in individuals with ALF admitted to intensive care unit. [2 weeks after admission to intensive care unit]

      Measuring body weight.

    Secondary Outcome Measures

    1. Mortality rates [2 weeks after admission to intensive care unit]

      Assessment of mortality rates in individuals with ALF admitted to intensive care unit.

    2. Morbidity rates [2 weeks after admission to intensive care unit]

      Assessment of morbidity rates in individuals with ALF admitted to intensive care unit..

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdallah Hussein Kamel Ibrahim, Resident Physician, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05879445
    Other Study ID Numbers:
    • Severe ALD in intensive care
    First Posted:
    May 30, 2023
    Last Update Posted:
    May 30, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of May 30, 2023