Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

University of Catania

Status: Completed

Conditions: Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)

Treatments: Drug: Acetyl-l-Carnitine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01223768

8-12-00 C

Details and patient eligibility

About

To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis

Exclusion criteria

• Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)
• Other exclusion criteria were the following: major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; acute superimposed liver injury;patients with metabolic disorders such as diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; any additional precipitating factors such as high protein intake (additional high-protein meals), constipation; illiteracy.

Trial design

0 participants in 2 patient groups, including a placebo group

Acetyl-L-carnitine

Experimental group

Treatment:

Drug: Acetyl-l-Carnitine

placebo

Placebo Comparator group

Treatment:

Drug: placebo