Hepatic Encephalopathy
Conditions
Keywords
Hepatic Encephalopathy, Acute Variceal Bleeding, Cirrhosis
Brief summary
The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding
Interventions
DRUGLactulose
30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days
10 grams by intravenous way for 24 hours. Duration of therapy: 7 days
DRUGRifaximin
2 tablets (400mg) three times daily. Duration of therapy: 7 days
DRUGPlacebo
Placebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days. Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days. Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days.
Sponsors
Hospital General de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
-Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria
Exclusion criteria
* Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder or dementia, presence of active bacterial or fungal infections, receiving antibiotics for any cause, previous diagnosis of hepatic encephalopathy and receiving therapy with lactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different from variceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renal failure. Therapy in the previous six months with any of the drugs that will be used in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of clinical hepatic encephalopathy | 7 days | Determined by West-Haven Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of minimal hepatic encephalopathy | 7 days | Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Development of adverse effects | 7 days | Side or adverse effect will be defined as an undesirable secondary effect which occurs in addition to the desired therapeutic effect of a drug or medication. Non serious side effect will be defined as an undesirable secondary effect that does not represents a risk for patient´s life or function. Particularly we will addressed: Diarrhea, bloating, nausea, vomiting, elevation of serum creatinine, flatulence, abdominal pain, constipation, headache, dizziness Serious side effect will be defined as an undesirable secondary effect that represents a risk for patient´s life or function. Particularly we will addressed: allergic reactions. |
Countries
Mexico
Outcome results
None listed