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Sponsored by: |
Hospital Universitari Vall d'Hebron Research Institute |
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Information provided by: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Hepatic Encephalopathy |
Drug: Albumin Drug: Sodium chloride 0.9% |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy. |
Estimated Enrollment: | 124 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Albumin: Active Comparator |
Drug: Albumin
Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
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Saline: Placebo Comparator |
Drug: Sodium chloride 0.9%
Day 0: 400-600 ml. Day 2: 200-400 ml.
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Juan Cordoba, MD | +34 93 274 6140 | jcordoba@vhebron.net |
Spain | |
Hospital Universitari Vall d'Hebron | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Juan Cordoba, MD +34 93 274 6140 jcordoba@vhebron.net | |
Principal Investigator: Juan Cordoba, MD | |
Hospital Clinic | Recruiting |
Barcelona, Spain, 08036 | |
Contact: Monica Guevara, MD mguevara@clinic.ub.es | |
Principal Investigator: Monica Guevara, MD | |
Hospital de Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: German Soriano, MD gsoriano@santpau.cat | |
Principal Investigator: German Soriano, MD |
Principal Investigator: | Juan Cordoba, MD | Hospital Universitari Vall d'Hebron |
Responsible Party: | Hospital ( Juan Cordoba ) |
Study ID Numbers: | ALFAE, EudraCT 2008-003376-21 |
Study First Received: | April 22, 2009 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00886925 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Hepatic encephalopathy Cirrhosis Albumin |
Liver Diseases Neurotoxicity Syndromes Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Liver Cirrhosis Brain Diseases Signs and Symptoms Mental Disorders Brain Injuries Dementia Metabolic Disorder Neurobehavioral Manifestations Hepatic Insufficiency Delirium |
Liver Failure Metabolic Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Brain Diseases, Metabolic |
Liver Diseases Neurotoxicity Syndromes Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Brain Diseases Signs and Symptoms Pathologic Processes Mental Disorders Neurobehavioral Manifestations Hepatic Insufficiency Delirium Liver Failure |
Metabolic Diseases Nervous System Diseases Poisoning Central Nervous System Diseases Confusion Encephalitis Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations Brain Diseases, Metabolic |