Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy

Condition(s) targeted: Hepatic Encephalopathy

Intervention: Albumin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Roma La Sapienza

Official(s) and/or principal investigator(s):
oliviero riggio, professor, Principal Investigator, Affiliation: Sapienza University of Rome

The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'

Official title: Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement

Secondary outcome: arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement

Detailed description: The outcome is the prevention of post tips hepatic encephalopathy

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cirrhotic patients

- TIPS placement

- Absence of Hepatic Encephalopathy at the enrolement

- Age > 18 years

- No pregnancy

Exclusion Criteria:

- Non-cirrhotic portal hypertension

- Previous liver transplantation

- Impossibility to attend the scheduled follow-up including the weekly visit as

outpatients during the first month after TIPS (see the description of follow-up below)

- Sings of overt hepatic encephalopathy as well as a history of persistent HE at entry.

The latter as a contraindication for TIPS placement

Starting date: September 2012
Last updated: December 16, 2013