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

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What is being collected

Data Collection

Who is being recruted

From 18 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: June 2023
See protocol details

Summary

Principal SponsorAssiut University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 20, 2023

Actual date on which the first participant was enrolled.

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)

Official TitleCauses, Complications and Outcomes of Severe Acute Liver Disease Cases Admitted to Intensive Care Units
NCT05879445
Principal SponsorAssiut University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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

2 exclusion criteria prevent from participating
Patients with known cardiac cirrhosis.

Patients with known pre-existing renal disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

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