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NCT Number: NCT06953921

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, Professor

CONTACT

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease.

    Time frame: 6 months

    assess the impact of albumin level on clinical course and outcomes of HE.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamdy S Mohamed, Assist.prof

CONTACT

+201111101934

Kerelos L Sweha, Resident

CONTACT

[email protected]

+201280416877

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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