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

NCT01559519 | Completed Phase 4 DMC

• 1 other identifier: 2012-000931-20
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatic Encephalopathy

Keywords

TIPS; albumin; hepatic encephalopathy; hyponatremia; hypovolemia; cirrhosis

Outcome Measures

Primary Outcomes (1)

• one or more episodes of hepatic encephalopathy (> grade 2 according to West Heven criteria)after TIPS placement

  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

  one month post tips

Secondary Outcomes (1)

• arterial blood pressure >120/80 mmHg and natremia >130 mg/dl in cirrhotic patients one month after TIPS placement

  one month after tips placement

Study Arms (1)

albumin

ACTIVE COMPARATOR

cirrhotic patients who underwent tips placement

Drug: Albumin

Interventions

Albumin 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.

Also known as: human albumin

albumin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic patients
• TIPS placement
• Absence of Hepatic Encephalopathy at the enrolement
• Age \> 18 years
• No pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Hepatic Encephalopathy; Hyponatremia; Hypovolemia; Fibrosis

Interventions

Albumins; Serum Albumin, Human

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Serum Albumin; Blood Proteins

Study Officials

• oliviero riggio, professor

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 21, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12