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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lactulose | Experimental |
| |
| L-ornithine L-aspartate | Experimental |
| |
| Rifaximin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of clinical hepatic encephalopathy | Determined by West-Haven Criteria | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Development of minimal hepatic encephalopathy | Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Development of adverse effects | 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. |
Inclusion Criteria:
-Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepatic encephalopathy according to PHES, CFF and West-Haven criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mexico | Mexico City | 06726 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30079329 | Derived | Higuera-de-la-Tijera F, Servin-Caamano AI, Salas-Gordillo F, Perez-Hernandez JL, Abdo-Francis JM, Camacho-Aguilera J, Alla SN, Jimenez-Ponce F. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018 Jul 10;2018:3015891. doi: 10.1155/2018/3015891. eCollection 2018. |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| C002939 | ornithylaspartate |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| L-ornithine L-aspartate | Drug | 10 grams by intravenous way for 24 hours. Duration of therapy: 7 days |
|
| Rifaximin | Drug | 2 tablets (400mg) three times daily. Duration of therapy: 7 days |
|
| Placebo | Drug | 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. |
|
| 7 days |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073893 |
| Sugars |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |