Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy

University of Catania

Status: Completed

Conditions: Hepatic Encephalopathy

Treatments: Dietary Supplement: ACETYL-L-CARNITINE; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01223742

8-12-00 B

Details and patient eligibility

About

The aim of this study was to evaluate the effect of exogenous ALC on the both physical and mental fatigue in mild and moderate encephalopatic patients.

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time >30 seconds;
• 2. Hyperammonemia (venous ammonia concentration >50 mmol/L);
• 3. Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy.

Exclusion criteria

• 1. Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
• 2. Acute superimposed liver injury;
• 3. Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
• 4. Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
• 5. Severe HE;
• 6. Administration of anti-HE medications such as neomycin, branched-chain amino acids;
• 7. Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics;
• 8. Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
• 9. Illiteracy.

Trial design

0 participants in 2 patient groups, including a placebo group

ACETYL-L-CARNITINE

Experimental group

Treatment:

Dietary Supplement: ACETYL-L-CARNITINE

placebo

Placebo Comparator group

Treatment:

Drug: placebo