Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis (ALFAE)
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.
Drug: Sodium chloride 0.9%
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.|
- Proportion of patients without hepatic encephalopathy [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
- Severity of encephalopathy assessed by CHESS and West-Haven [ Time Frame: Admission to the hospital (up to day 14) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Albumin||
Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
|Placebo Comparator: Saline||
Drug: Sodium chloride 0.9%
Day 0: 400-600 ml. Day 2: 200-400 ml.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886925
|Sabadell, Barcelona, Spain|
|Barcelona, Spain, 08036|
|Hospital de Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||Juan Cordoba, MD||Hospital Universitari Vall d'Hebron|