NCT06953921

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 16, 2025

Last Update Submit

April 23, 2025

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum albumin ALT AST

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Kerelos L Sweha, Resident

CONTACT

+201280416877kerolos_latief_post@med.sohag.edu.eg

Hamdy S Mohamed, Assist.prof

CONTACT

+201111101934

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal medicine resident

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 1, 2025

Study Start

March 12, 2025

Primary Completion

September 12, 2025

Study Completion

September 12, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

EG(1)