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

University of Roma La Sapienza

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cirrhotic Patients Undergoing TIPS Placement

Treatments: Drug: lattulose and rifaximine

Study type: Interventional

Funder types: Other

Identifiers

NCT02931123

OR-201

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

standard

No Intervention group

treatment

Experimental group

Description:

rifaximine and lattulose plus low proteine diet

Treatment:

Drug: lattulose and rifaximine