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

NCT ID: NCT06953921

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-12

Study Completion Date

2025-09-12

Brief Summary

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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

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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

Conditions

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Hepatic Encephalopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Kerelos Latif sweha

Internal medicine resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Kerelos L Sweha, Resident

Role: CONTACT

+201280416877

Hamdy S Mohamed, Assist.prof

Role: CONTACT

+201111101934

Facility Contacts

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Magdy M Amin, Professor

Role: primary

Other Identifiers

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Soh-Med--25-3-02MS

Identifier Type: -

Identifier Source: org_study_id

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