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

Hospital General de Mexico

Status and phase: Completed; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: Lactulose; Drug: L-ornithine L-aspartate; Drug: Placebo; Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT02158182

DI/14/107/03/028

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups, including a placebo group

lactulose

Experimental group

Treatment:

Drug: Lactulose

L-ornithine L-aspartate

Experimental group

Treatment:

Drug: L-ornithine L-aspartate

Rifaximin

Experimental group

Treatment:

Drug: Rifaximin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo