Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
Phase 4
Completed
- Conditions
- Hepatic Encephalopathy
- Interventions
- Registration Number
- NCT02158182
- Lead Sponsor
- Hospital General de Mexico
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lactulose Lactulose - L-ornithine L-aspartate L-ornithine L-aspartate - Rifaximin Rifaximin - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Development of clinical hepatic encephalopathy 7 days Determined by West-Haven Criteria
- Secondary Outcome Measures
Name Time Method Development of minimal hepatic encephalopathy 7 days Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)
Trial Locations
- Locations (1)
Hospital General de Mexico
🇲🇽Mexico City, Mexico