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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
Sponsor:
Information provided by (Responsible Party):
MARIA DE FATIMA HIGUERA DE LA TIJERA, 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

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: Lactulose Drug: L-ornithine L-aspartate Drug: Rifaximin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: lactulose Drug: Lactulose
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

Experimental: Rifaximin Drug: Rifaximin
2 tablets (400mg) three times daily. Duration of therapy: 7 days

Placebo Comparator: Placebo Drug: 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.





Primary Outcome Measures :
  1. Development of clinical hepatic encephalopathy [ Time Frame: 7 days ]
    Determined by West-Haven Criteria


Secondary Outcome Measures :
  1. Development of minimal hepatic encephalopathy [ Time Frame: 7 days ]
    Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)


Other Outcome Measures:
  1. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Mexico
Hospital General de Mexico
Mexico City, Mexico, 06726
Sponsors and Collaborators
Hospital General de Mexico

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MARIA DE FATIMA HIGUERA DE LA TIJERA, MD, MSc., Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT02158182     History of Changes
Other Study ID Numbers: DI/14/107/03/028
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico:
Hepatic Encephalopathy
Acute Variceal Bleeding
Cirrhosis

Additional relevant MeSH terms:
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Hemorrhage
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Lactulose
N-Methylaspartate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs