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

Not Applicable

Completed

• Conditions: Hepatic Encephalopathy
• Interventions: Dietary Supplement: ACETYL-L-CARNITINE; Drug: placebo

• Registration Number: NCT01223742
• Lead Sponsor: University of Catania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2000-12
• Study Start: 2002-06
• Study Completion: 2006-12
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Last Update Submitted: 2010-10-18
• Study First Posted: 2010-10-19
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACETYL-L-CARNITINE	ACETYL-L-CARNITINE	-
placebo	placebo	-

Trial Locations

Locations (1)

Cannizzaro Hospital; 🇮🇹 Catania, Italy