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Completed

NCT Number: NCT02158182

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

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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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Mexico

Mexico City, 06726, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Development of clinical hepatic encephalopathy

    Time frame: 7 days

    Determined by West-Haven Criteria

Secondary outcomes

  1. Development of minimal hepatic encephalopathy

    Time frame: 7 days

    Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital General de Mexico

Other Gov

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2014
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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