Hepatic Encephalopathy Clinical Trial
Official title:
Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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