ALBUMIN INFUSION TO PREVENT HEPATIC ENCEPHALOPATHY AFTER TIPS

• Conditions: PREVENTION OF HEPATIC ENCEPHALOPATHY IN CIRRHOTIC PATIENTS WHO UNDERGO TIPS PLACEMENT; MedDRA version: 14.1Level: PTClassification code 10019660Term: Hepatic encephalopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-000931-20-IT
• Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

TIPS PLACEMENT
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

PRESENCE OF HEPATIC ENCEPHALOPATHY
NON CIRRHOTIC PORTAL HYPERTENSION
PREVIOUS ORGAN LIVER TRANSPLANTATION

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: PREVENTION OF HEPATIC ENCEPHALOPATHY IN THE FIRST MONTH AFTER TIPS;Secondary Objective: REDUCTION OF HYPOVOLEMIA, HYPONATRIEMIA, HYPERCREATININEMIA;Primary end point(s): OCCURRENCE OF UNLESS ONE EPISODE OF HEPATIC ENCEPHALOPATHY ONE MONTH AFTER TIPS PLACEMENT;Timepoint(s) of evaluation of this end point: ONE MONTH

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): IMPROVEMENT OF HYPOVOLEMIA;Timepoint(s) of evaluation of this end point: ONE MONTH