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

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT01559519
Collaborator
(none)
20
Enrollment
1
Arm
15
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The outcome is the prevention of post tips hepatic encephalopathy

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: albumin

cirrhotic patients who underwent tips placement

Drug: Albumin
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.
Other Names:
  • human albumin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

    • Principal Investigator: oliviero riggio, professor, Sapienza University of Rome

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof oliviero Riggio, Professor, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT01559519
    Other Study ID Numbers:
    • 2012-000931-20
    First Posted:
    Mar 21, 2012
    Last Update Posted:
    Dec 17, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Prof oliviero Riggio, Professor, University of Roma La Sapienza
    TIPS
    albumin
    hepatic encephalopathy
    hyponatremia
    hypovolemia
    cirrhosis
    Additional relevant MeSH terms:
    Hepatic Encephalopathy
    Brain Diseases

    Study Results

    No Results Posted as of Dec 17, 2013