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Recruiting NCT06953921

Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital

Observational Hepatic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatic Encephalopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease. assess the impact of albumin level on clinical course and outcomes of HE.

Detailed description

sample size calculation will be performed based on anticipated incidence rates of HE and variability in serum albumin levels, aiming for a study population of 100-150 patients to achieve adequate statistical power.

\- All patients included in the study will be subjected to : Glasgow Coma Scale (GCS) score. Clinical Assessment: Baseline evaluation of patients to confirm chronic liver disease diagnosis and determine clinical characteristics.

History of prior episodes of HE, presence of ascites, variceal bleeding, and other complications of chronic liver disease .

Age, gender, etiology of cirrhosis (e.g., viral hepatitis, alcohol), comorbid conditions (e.g., diabetes, hypertension)

* Laboratory investigation :

Serum albumin level AST ALT Total bilirubin and direct CBC Serum creatinine Proth time and concetntration

Primary outcome measures

  • assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease. [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • patients aged >18 years.
  • Confirmed chronic liver disease (by imaging ,
  • liver function tests , and clinical history).
  • Diagnosed with hepatic encephalopathy based on clinical criteria.
  • Patients able to provide informed consent.

Exclusion criteria

  • Patients age less than 18 years old
  • Acute liver failure.
  • Chronic renal failure on dialysis.
  • Pregnant women.
  • Patients with active malignancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Egypt · 1 center
  • Sohag university hospital — Sohag

Identifiers

NCT: NCT06953921 · Soh-Med--25-3-02MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗