Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
- Registration Number
- NCT01559519
- Lead Sponsor
- University of Roma La Sapienza
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description albumin Albumin cirrhotic patients who underwent tips placement
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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