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

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ClinicalTrials.gov Identifier: NCT01559519
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Prof oliviero Riggio, University of Roma La Sapienza

Study Description
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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
Hepatic Encephalopathy Drug: Albumin Phase 4

Detailed Description:
The outcome is the prevention of post tips hepatic encephalopathy
Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arms and Interventions
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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 Name: human albumin


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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Principal Investigator: oliviero riggio, professor University of Roma La Sapienza
More Information
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Responsible Party: Prof oliviero Riggio, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01559519    
Other Study ID Numbers: 2012-000931-20
First Posted: March 21, 2012    Key Record Dates
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:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
 Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases