Cognitive Function of Alcoholic Compensated Liver Cirrhosis

Completed

• Conditions: Alcoholic Liver Disease

• Registration Number: NCT04557774
• Lead Sponsor: Chuncheon Sacred Heart Hospital

Brief Summary

Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis

Detailed Description

Hepatic encephalopathy (HE) is one of the important complications of liver cirrhosis (LC). HE exhibits alterations in cognitive, psychomotor-intellectual, emotional, behavioral, or fine-motor functions. Approximately 22-74 % of patients with non-fulminant HE have MHE with a frequency proportional to the patient age and the severity of the liver disease. Patients with MHE exhibit disability in most functional behaviors such as social connection, alertness, emotional behavior, sleep, work, and leisure.

Alcohol consumption itself has a toxic effect on the brain. It has been documented that there is a neuronal loss in the cerebral cortex, hypothalamus, hippocampus, septal region, and cerebellum of an alcoholic brain.

The major causes of LC are hepatitis B/C viral infection and chronic alcohol consumption. The most widely accepted theory of HE pathogenesis is that toxic substances derived from the gut affect cerebral function after liver dysfunction or portosystemic shunting. This proposed pathogenetic mechanism could apply to viral compensated LC. However, it is difficult to explain the development of MHE in patients with alcoholic LC in this manner.

Therefore, patients with alcoholic LC may have different cognitive dysfunction as compared to patients with viral LC.

Study Timeline

• Study Start: 2011-10-01
• Primary Completion: 2013-03-01
• Study Completion: 2020-05
• Status Verified: 2020-09
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Those who agreed to participate in this study and signed a written consent
• Those who have no evidence of neurological impairment

Exclusion Criteria

• Those who have decompensated liver cirrhosis
• Those who have a high MELD score (≥20)
• Those who have OHE during admission
• Those who have parients' refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI	10 years	Compare the body mass index
Liver function	10 years	Compare the liver enzyme level Serum biochemical parameters included total bilirubin(mg/dL), alanine aminotransferase(ALT(IU/L)), haptoglobin(mg/dL), aspartate aminotransferase (AST (IU/L)), gamma glutamyltranspeptidase (GGT(IU/L)), alkaline phosphatase (ALP(IU/L)), albumin(g/dL), blood urea nitrogen(mg/dL), creatinine(mg/dL), α-fetoprotein (AFP(ng/mL)), prothrombin time, blood glucose(mg/dL), triglycerides(mg/dL), and total cholesterol(mg/dL).
Cognitive function (Neuropsychological test)	10 years	Assessment to measure cognitive function using neuropsychological test

Trial Locations

Locations (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwondo, Korea, Republic of