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Completed

NCT Number: NCT01223742

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

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.

Completed

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cannizzaro Hospital

Catania, 95126, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACETYL-L-CARNITINE

Dietary Supplement

2 g acetylcarnitine taken orally twice a day.

Placebo

Drug

placebo twice per day

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Oct 19, 2010
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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