Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
NCT ID: NCT02401490
Last Updated: 2017-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
128 participants
INTERVENTIONAL
2015-04-30
2018-03-31
Brief Summary
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Detailed Description
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* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Human albumin
human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.
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
saline serum 0.9%
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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German Soriano
Role: PRINCIPAL_INVESTIGATOR
Hospital de la Santa creu i Sant Pau - Barcelona
Jordi Sanchez
Role: PRINCIPAL_INVESTIGATOR
Corporació Sanitària Parc Taulí, Sabadell
Helena Masnou
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Germans Trias i Pujol, Badalona
Núria Cañete
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Marta Martín
Role: PRINCIPAL_INVESTIGATOR
Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí
Elsa Solà
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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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, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Joan Genescà, MD PhD
Role: primary
Other Identifiers
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2014-004809-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BETA
Identifier Type: -
Identifier Source: org_study_id