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Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

This study has been completed.
Sponsor:
Information provided by:
University of Catania
ClinicalTrials.gov Identifier:
NCT01223768
First received: October 18, 2010
Last updated: NA
Last verified: December 2000
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223768

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

No publications provided

ClinicalTrials.gov Identifier: NCT01223768     History of Changes
Other Study ID Numbers: 8-12-00 C
Study First Received: October 18, 2010
Last Updated: October 18, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion
 Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Acetylcarnitine
Carnitine
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013