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

Last updated: May 19, 2018
Sponsor: Hospital General de Mexico
Overall Status: Completed

Phase

4

Condition

Hemorrhage

Liver Disorders

Hepatic Encephalopathy

Treatment

N/A

Clinical Study ID

NCT02158182
DI/14/107/03/028
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

-Cirrhotic patients with acute variceal bleeding, without minimal or clinical hepaticencephalopathy according to PHES, CFF and West-Haven criteria

Exclusion

Exclusion Criteria:

  • Age under 18 year-old or over 65 year-old, with any other neuropsychiatric disorder ordementia, presence of active bacterial or fungal infections, receiving antibiotics forany cause, previous diagnosis of hepatic encephalopathy and receiving therapy withlactulose, rifaximin, L-ornithine L-aspartate, source of bleeding different fromvariceal origin, serum creatinine greater than 2.0 mg/dl or with chronic renalfailure. Therapy in the previous six months with any of the drugs that will be used inthis clinical trial.

Study Design

Total Participants: 88
Study Start date:
July 01, 2014
Estimated Completion Date:
June 30, 2016

Connect with a study center

  • Hospital General de Mexico

    Mexico City, 06726
    Mexico

    Site Not Available

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