Hepatic Encephalopathy
Conditions
Keywords
minimal hepatic encephalopathy, L-ornithine-L-aspartate, psychometric test, critical flicker frequency, quality of life, Treatment, Health-related quality of life
Brief summary
The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.
Detailed description
Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.
Interventions
L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days
DRUGplacebo
Placebo: 5 g (1 sachet) three times per day for 60 days
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency
Exclusion criteria
* Hepatic encephalopathy grade 1 to 4 * Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin) * Psychoactive substance use within 72 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychometric tests and critical flicker frequency | day 0, 15, 30, 45 and 60 |
Secondary
| Measure | Time frame |
|---|---|
| Ammonia concentration | time 0 and 60 days after |
| Health-related quality of life | time 0 and 60 days after |
| Safety analysis | time 0 and 60 days after |
Countries
Brazil
Outcome results
None listed