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

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).

Study Overview

• Status: Unknown
• Conditions: Hepatic Encephalopathy; Cirrhosis
• Intervention / Treatment: Drug: Placebo; Drug: Human albumin

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).

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joan Genescà Ferrer; Email: jgenesca@vhebron.net
• Study Contact Backup: Name: Inmaculada Fuentes Camps, MD; Phone Number: 4881 934894113; Email: usic@vhir.org

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: Joan Genescà, MD PhD
    • Sub-Investigator: Meritxell Ventura, MD
  • Barcelona, Spain
    • Recruiting
    • Hospital del Mar
    • Principal Investigator: Nuria Cañete, MD
  • Barcelona, Spain
    • Recruiting
    • Hospital Clínic de Barcelona
    • Principal Investigator: Elsa Solà, MD PhD
  • Barcelona, Spain
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Principal Investigator: German Soriano, MD PhD
  • Barcelona
    • Badalona, Barcelona, Spain
      • Recruiting
      • Hospital Universitari Germans Trias i Pujol
      • Principal Investigator: Helena Masnou, MD PhD
    • Sabadell, Barcelona, Spain
      • Recruiting
      • Corporació Sanitària Parc Taulí
      • Principal Investigator: Jordi Sánchez, MD
    • Sant Joan Despí, Barcelona, Spain
      • Recruiting
      • Hospital de Sant Joan Despí Moisès Broggi
      • Principal Investigator: Marta Martín, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Human albumin; human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.	Drug: Human albumin; 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.
PLACEBO_COMPARATOR: placebo; saline serum 0.9%	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival at 180 days.	180 days

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: German Soriano, Hospital de la Santa creu i Sant Pau - Barcelona; Principal Investigator: Jordi Sanchez, Corporació Sanitària Parc Taulí, Sabadell; Principal Investigator: Helena Masnou, Hospital Universitari Germans Trias i Pujol, Badalona; Principal Investigator: Núria Cañete, Hospital del Mar; Principal Investigator: Marta Martín, Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí; Principal Investigator: Elsa Solà, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (ESTIMATE): March 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: BETA; 2014-004809-33 (EUDRACT_NUMBER)