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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lactulose

Group Type EXPERIMENTAL

Lactulose

Intervention Type 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

Group Type EXPERIMENTAL

L-ornithine L-aspartate

Intervention Type DRUG

10 grams by intravenous way for 24 hours. Duration of therapy: 7 days

Rifaximin

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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

Intervention Type DRUG

L-ornithine L-aspartate

10 grams by intravenous way for 24 hours. Duration of therapy: 7 days

Intervention Type DRUG

Rifaximin

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No