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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hepatic Encephalopathy, Cirrhosis

Intervention / Treatment
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* Drug: Human albumin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human albumin<br>human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose. | Drug: Human albumin<br>* 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.<br>|
| Placebo Comparator: placebo<br>saline serum 0.9% | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 180 days. |  | 180 days |