Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
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|ClinicalTrials.gov Identifier: NCT02158182|
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Encephalopathy||Drug: Lactulose Drug: L-ornithine L-aspartate Drug: Rifaximin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Three Different Schemes:Lactulose, L-ornithine L-aspartate, or Rifaximin, Versus Placebo, as Primary Prophylaxis of the Development of Hepatic Encephalopathy After Acute Variceal Bleeding in Cirrhotic Patients|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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
|Experimental: L-ornithine L-aspartate||
Drug: L-ornithine L-aspartate
10 grams by intravenous way for 24 hours. Duration of therapy: 7 days
2 tablets (400mg) three times daily. Duration of therapy: 7 days
|Placebo Comparator: Placebo||
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.
- Development of clinical hepatic encephalopathy [ Time Frame: 7 days ]Determined by West-Haven Criteria
- Development of minimal hepatic encephalopathy [ Time Frame: 7 days ]Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)
- Development of adverse effects [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158182
|Hospital General de Mexico|
|Mexico City, Mexico, 06726|