ALBUMIN
DrugAlbumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
NCT Number: NCT00886925
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Parc Tauli, Sabadell, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
Day 0: 400-600 ml. Day 2: 200-400 ml.
Time frame: Day 3
Time frame: Admission to the hospital (up to day 14)
Hospital Universitari Vall d'Hebron Research Institute
Other
Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.
Acronym: ALFAE
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