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

Hepatic Encephalopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158182
• Other study ID #: DI/14/107/03/028
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2018
• Source: Hospital General de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hemorrhage
• Hepatic Encephalopathy

Intervention

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
• L-ornithine L-aspartate
10 grams by intravenous way for 24 hours. Duration of therapy: 7 days
• Rifaximin
2 tablets (400mg) three times daily. Duration of therapy: 7 days
• 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.

Locations

Country	Name	City	State
Mexico	Hospital General de Mexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	7 days
Primary	Development of clinical hepatic encephalopathy	Determined by West-Haven Criteria	7 days
Secondary	Development of minimal hepatic encephalopathy	Determined by psychometric hepatic encephalopathy score (PHES) and critical flicker frequency (CFF)	7 days