search
Back to results

Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy (BETA)

Primary Purpose

Hepatic Encephalopathy, Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Human albumin
Placebo
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18 and 85 years.
  2. Liver cirrhosis defined by previous clinical data or liver biopsy.
  3. Presence of an episode of acute hepatic encephalopathy of grade> 2.
  4. Sign the informed consent

Exclusion Criteria:

  1. Pregnant or breast-feeding.
  2. Terminal illness.
  3. Presence of Acute-on-chronic liver failure.
  4. Needing for intensive support measures.
  5. Active gastrointestinal bleeding.
  6. neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy.
  7. Clinical situations in which it is contraindicated to administer intravenous albumin.
  8. MELD score less than 15 or greater than 25 at the time of inclusion
  9. Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.

Sites / Locations

  • Hospital Universitari Germans Trias i PujolRecruiting
  • Corporació Sanitària Parc TaulíRecruiting
  • Hospital de Sant Joan Despí Moisès BroggiRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Human albumin

placebo

Arm Description

human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.

saline serum 0.9%

Outcomes

Primary Outcome Measures

Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).

Secondary Outcome Measures

Survival at 180 days.

Full Information

First Posted
March 24, 2015
Last Updated
December 27, 2017
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Instituto de Salud Carlos III
search

1. Study Identification

Unique Protocol Identification Number
NCT02401490
Brief Title
Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
Acronym
BETA
Official Title
Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Instituto de Salud Carlos III

4. Oversight

5. Study Description

Brief Summary
To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).
Detailed Description
To evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 30, 90 and 180 days. to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. To analyze whether albumin administration reduces hospitalization requirement. To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Human albumin
Arm Type
Active Comparator
Arm Description
human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
saline serum 0.9%
Intervention Type
Drug
Intervention Name(s)
Human albumin
Intervention Description
1.5gr/Kg/day at least in the 24-48 hours after the hospitalization and 1.0 gr/Kg/day at 72 hours after the first dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Survival at 180 days.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 85 years. Liver cirrhosis defined by previous clinical data or liver biopsy. Presence of an episode of acute hepatic encephalopathy of grade> 2. Sign the informed consent Exclusion Criteria: Pregnant or breast-feeding. Terminal illness. Presence of Acute-on-chronic liver failure. Needing for intensive support measures. Active gastrointestinal bleeding. neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy. Clinical situations in which it is contraindicated to administer intravenous albumin. MELD score less than 15 or greater than 25 at the time of inclusion Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Genescà Ferrer
Email
jgenesca@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Inmaculada Fuentes Camps, MD
Phone
934894113
Ext
4881
Email
usic@vhir.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
German Soriano
Organizational Affiliation
Hospital de la Santa creu i Sant Pau - Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordi Sanchez
Organizational Affiliation
Corporació Sanitària Parc Taulí, Sabadell
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helena Masnou
Organizational Affiliation
Hospital Universitari Germans Trias i Pujol, Badalona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Núria Cañete
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marta Martín
Organizational Affiliation
Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elsa Solà
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Masnou, MD PhD
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Sánchez, MD
Facility Name
Hospital de Sant Joan Despí Moisès Broggi
City
Sant Joan Despí
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Martín, MD PhD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Genescà, MD PhD
First Name & Middle Initial & Last Name & Degree
Meritxell Ventura, MD
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa Solà, MD PhD
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
German Soriano, MD PhD
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Cañete, MD

12. IPD Sharing Statement

Learn more about this trial

Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy

We'll reach out to this number within 24 hrs