Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
BETA
2 other identifiers
interventional
128
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2015
Typical duration for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedDecember 28, 2017
December 1, 2017
2.9 years
March 24, 2015
December 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
90 days
Secondary Outcomes (1)
Survival at 180 days.
180 days
Study Arms (2)
Human albumin
ACTIVE COMPARATORhuman albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.
placebo
PLACEBO COMPARATORsaline serum 0.9%
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 27, 2015
Study Start
April 1, 2015
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
December 28, 2017
Record last verified: 2017-12