Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.

Detailed Description
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Hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated with poor prognosis. The most common presentation is an acute episode of hepatic encephalopathy precipitated by factors that increase the exposure of the brain to ammonia. Current therapies are based on measures that decrease plasma ammonia and counteract the effect of factors such as infection or electrolyte's disturbances. Brain edema and abnormalities of cerebral blood flow appear to be important. Part of the impairment of astrocyte function could be related to an increase of oxidative stress injury. In patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma is usually low. Administration of human albumin in patients with hepatorenal syndrome and spontaneous bacterial peritonitis has a major impact on the prognosis of these complications. Albumin prevents circulatory dysfunction and renal failure. The mechanisms of action may include the maintenance of oncotic pressure and a scavenger effect of toxic substances present in blood. Albumin has also shown beneficial effects in neurological injury secondary to stroke, probably in relation to this scavenger effect. The administration of intravenous albumin to patients with hepatic encephalopathy may have beneficial effects on the course of encephalopathy.

Official Title
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Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Albumin
* Drug: Sodium chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhosis of the liver Hepatic encephalopathy stage>1 Completion of a standardized protocol to investigate precipitating factors Informed consent by next of keen Exclusion Criteria: Pregnancy Terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy) Need of advanced life support (mechanical ventilation, ionotropic support, dialysis) Need of albumin administration (e.g. bacterial spontaneous peritonitis) Contraindication for albumin administration (e.g. cardiac failure)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albumin<br> | Drug: Albumin<br>* Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.<br>|
| Placebo Comparator: Saline<br> | Drug: Sodium chloride 0.9%<br>* Day 0: 400-600 ml. Day 2: 200-400 ml.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients without hepatic encephalopathy |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of encephalopathy assessed by CHESS and West-Haven |  | Admission to the hospital (up to day 14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Albumin, Hepatic encephalopathy, Cirrhosis