Cirrhosis, Hepatic Encephalopathy
Conditions
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).
Interventions
DRUGHuman 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.
DRUGPlacebo
Sponsors
Instituto de Salud Carlos III
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation). | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Survival at 180 days. | 180 days |
Countries
Spain
Contacts
Primary ContactJoan Genescà Ferrer
Backup ContactInmaculada Fuentes Camps, MD
Outcome results
None listed