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

Primary Purpose

Hepatic Encephalopathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Albumin
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy focused on measuring TIPS, albumin, hepatic encephalopathy, hyponatremia, hypovolemia, cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    albumin

    Arm Description

    cirrhotic patients who underwent tips placement

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    March 6, 2012
    Last Updated
    December 16, 2013
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01559519
    Brief Title
    Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy
    Official Title
    Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatic Encephalopathy
    Keywords
    TIPS, albumin, hepatic encephalopathy, hyponatremia, hypovolemia, cirrhosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    albumin
    Arm Type
    Active Comparator
    Arm Description
    cirrhotic patients who underwent tips placement
    Intervention Type
    Drug
    Intervention Name(s)
    Albumin
    Other Intervention Name(s)
    human albumin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement
    Description
    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 Outcome Measure Information:
    Title
    arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    oliviero riggio, professor
    Organizational Affiliation
    University of Roma La Sapienza
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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