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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01559519

Enrollment

Registered

2012-03-21

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

TIPS, albumin, hepatic encephalopathy, hyponatremia, hypovolemia, cirrhosis

Brief summary

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

Detailed description

The outcome is the prevention of post tips hepatic encephalopathy

Interventions

DRUGAlbumin

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement	one month post tips	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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026