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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559519
First Posted: March 21, 2012
Last Update Posted: December 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof oliviero Riggio, University of Roma La Sapienza
  Purpose
The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'

Condition Intervention Phase
Hepatic Encephalopathy Drug: Albumin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Prof oliviero Riggio, University of Roma La Sapienza:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement [ Time Frame: 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


Enrollment: 20
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: human albumin

Detailed Description:
The outcome is the prevention of post tips hepatic encephalopathy
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559519


Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: oliviero riggio, professor Sapienza University of Rome
  More Information

Responsible Party: Prof oliviero Riggio, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01559519     History of Changes
Other Study ID Numbers: 2012-000931-20
First Submitted: March 6, 2012
First Posted: March 21, 2012
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Prof oliviero Riggio, University of Roma La Sapienza:
TIPS
albumin
hepatic encephalopathy
hyponatremia
hypovolemia
cirrhosis

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases