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

NCT ID: NCT01559519

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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The outcome is the prevention of post tips hepatic encephalopathy

Conditions

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Hepatic Encephalopathy

Keywords

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TIPS albumin hepatic encephalopathy hyponatremia hypovolemia cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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albumin

cirrhotic patients who underwent tips placement

Group Type ACTIVE_COMPARATOR

Albumin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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human albumin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Prof oliviero Riggio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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oliviero riggio, professor

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Other Identifiers

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2012-000931-20

Identifier Type: -

Identifier Source: org_study_id