Back to resultsAcetyl-L-Carnitine In Severe Hepatic Encephalopathy
Primary Purpose
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acetyl-l-Carnitine
placebo
Sponsored by
About this trial
This is an interventional trial for Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)
Eligibility Criteria
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.
Sites / Locations
- Cannizzaro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acetyl-L-carnitine
placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01223768
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT01223768
Brief Title
Acetyl-L-Carnitine In Severe Hepatic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2000
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Catania
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Acetyl-L-carnitine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetyl-l-Carnitine
Intervention Description
2g per day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
twice per day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
Cannizzaro Hospital
City
Catania
ZIP/Postal Code
95126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Acetyl-L-Carnitine In Severe Hepatic Encephalopathy
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