Status:
COMPLETED
Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
Lead Sponsor:
University of Catania
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
40-65 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01223742
Start Date
June 1 2002
End Date
December 1 2006
Last Update
October 19 2010
Active Locations (1)
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1
Cannizzaro Hospital
Catania, Italy, 95126