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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
88
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
2 tablets (400mg) three times daily. Duration of therapy: 7 days
Hospital General de Mexico
Mexico City, Mexico
Development of clinical hepatic encephalopathy
Determined by West-Haven Criteria
Time frame: 7 days
Development of minimal hepatic encephalopathy
Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)
Time frame: 7 days
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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.