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Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223768
First Posted: October 19, 2010
Last Update Posted: October 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Catania
  Purpose
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.

Condition Intervention
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale) Drug: Acetyl-l-Carnitine Drug: placebo

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by University of Catania:

Study Start Date: July 2002
Estimated Study Completion Date: December 2005
Arms Assigned Interventions
Experimental: Acetyl-L-carnitine Drug: Acetyl-l-Carnitine
2g per day
Placebo Comparator: placebo Drug: placebo
twice per day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223768


Locations
Italy
Cannizzaro Hospital
Catania, Italy, 95126
Sponsors and Collaborators
University of Catania
  More Information

ClinicalTrials.gov Identifier: NCT01223768     History of Changes
Other Study ID Numbers: 8-12-00 C
First Submitted: October 18, 2010
First Posted: October 19, 2010
Last Update Posted: October 19, 2010
Last Verified: December 2000

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Acetylcarnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Nootropic Agents