Hepatic EncephalopathyNCT06953921
Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital
An observational study of Hepatic Encephalopathy, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2025to 12 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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 100patients to achieve adequate statistical power.
Who may be able to join
- 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.
Who cannot join
- Patients age less than 18 years old
- Acute liver failure.
- Chronic renal failure on dialysis.
- Pregnant women.
- Patients with active malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hamdy S Mohamed, Assist.prof contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
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.
Read the 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
- Conditions
- Hepatic Encephalopathy
- Medical subject headings
- Hepatic Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 Mar 2025
- Primary completion12 Sep 2025 (estimated)
- Study completion12 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerelos Latif sweha, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953921
- Sponsor's protocol ID
- Soh-Med--25-3-02MS
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06953921
- Acronym / sponsor ID
- Soh-Med--25-3-02MS
- Conditions
- Hepatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 12 Sep 2025 (estimated)
- Study completion
- 12 Sep 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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 100patients to achieve adequate statistical power.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients age less than 18 years old
- Acute liver failure.
- Chronic renal failure on dialysis.
- Pregnant women.
- Patients with active malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamdy S Mohamed, Assist.prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerelos L Sweha, Resident (+201280416877, kerolos_latief_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.