NCT01559519
Completed
Phase 4
Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt
University of Roma La Sapienza0 sites20 target enrollmentSeptember 2012
Overview
- Phase
- Phase 4
- Intervention
- Albumin
- Conditions
- Hepatic Encephalopathy
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 20
- Primary Endpoint
- one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Prof oliviero Riggio
Professor
University of Roma La Sapienza
Eligibility 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
Arms & Interventions
albumin
cirrhotic patients who underwent tips placement
Intervention: Albumin
Outcomes
Primary Outcomes
one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement
Time Frame: 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 Outcomes
- arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement(one month after tips placement)
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