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

Phase 4CompletedNCT01559519

University of Roma La Sapienza20 enrolled

Overview

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

The outcome is the prevention of post tips hepatic encephalopathy

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hepatic Encephalopathy

Interventions

AlbuminDRUG

albumin 20% 1 g/Kg body weight for the first two days after TIPS followed by 0,5 g/Kg body weight at day 4 and then 0,5 g/Kg body weight once a week for three weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

evaluate the efficacy of albumin infusion to prevent the occurrence of hepatic encephalopathy (\> grade 2 according to West Heven criteria)one months after tips placement

Time frame: one month post tips

Secondary Outcomes

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

improving the hypovolemia, evaluated by the arterial blood pressure value, and hyponatremia (\<130 mg/dl)after albumine infusion for one month after tips placement

Time frame: one month after tips placement

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.