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

PHASE4CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Hepatic Encephalopathy
Interventions
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."

Trial Locations (1)

06726

Hospital General de Mexico, Mexico City

All Listed Sponsors
lead

Hospital General de Mexico

OTHER_GOV

NCT02158182 - Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding | Biotech Hunter | Biotech Hunter