Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223768
• Other study ID #: 8-12-00 C
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: July 2002
• Est. completion date: December 2005

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)

Intervention

Drug:
• Acetyl-l-Carnitine
2g per day
• 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,