A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Rifaximin

Criteria

Inclusion Criteria:

• consecutive cirrhotic patients undergoing TIPS

Exclusion Criteria:

• age >75 years; bilirubin levels >5 mg/dl; creatinine levels >3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score >11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score >18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state < 26).