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

This study is not yet open for participant recruitment.
Verified March 2012 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Prof oliviero Riggio, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01559519
First received: March 6, 2012
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Albumine Infusion in the Prevention of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    improving the hypovolemia, evaluated by the arterial blood pressure value, and hyponatremia (<130 mg/dl)after albumine infusion for one month after tips placement


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2012 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559519

Contacts
Contact: oliviero riggio, professor 00390649972001 oliviero.riggio@uniroma1.it
Contact: manuela merli, professor 00390649972001 manuela.merli@uniroma1.it

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

No publications provided

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
Study First Received: March 6, 2012
Last Updated: March 21, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Metabolic Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 19, 2013