NCT02158182

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Hospital General de Mexico · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatic Encephalopathy

Interventions

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

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-06-06
• Last updated: 2018-05-22

Locations

1 site across 1 country: Mexico