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

Hepatic Encephalopathy Clinical Trial

Official title:

ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223742
• Other study ID #: 8-12-00 B
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: June 2002
• Est. completion date: December 2006

Study information

• Verified date: December 2000
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2006
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Dietary Supplement:
• ACETYL-L-CARNITINE
2 g acetylcarnitine taken orally twice a day.

Drug:
• placebo
placebo twice per day

Locations

Country	Name	City	State
Italy	Cannizzaro Hospital	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy,