A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY
Phase 1
- Conditions
- Cirrhotic Patients Undergoing TIPS Placement
- Interventions
- Registration Number
- NCT02931123
- Lead Sponsor
- University of Roma La Sapienza
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 58
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatment lattulose and rifaximine rifaximine and lattulose plus low proteine diet
- Primary Outcome Measures
Name Time Method incidence of hepatic encephalopathy one month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Clinical Medicine
🇮🇹Rome, RM, Italy