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Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis
This study is currently recruiting participants.
Verified by Hospital Universitari Vall d'Hebron Research Institute, April 2009
First Received: April 22, 2009   No Changes Posted
Sponsored by: Hospital Universitari Vall d'Hebron Research Institute
Information provided by: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT00886925
  Purpose

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
Hepatic Encephalopathy
Drug: Albumin
Drug: Sodium chloride 0.9%
Phase IV

MedlinePlus related topics: Cirrhosis
Drug Information available for: Sodium chloride
U.S. FDA Resources
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.

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Proportion of patients without hepatic encephalopathy [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of encephalopathy assessed by CHESS and West-Haven [ Time Frame: Admission to the hospital (up to day 14) ] [ Designated as safety issue: No ]

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
Albumin: Active Comparator Drug: Albumin
Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
Saline: Placebo Comparator Drug: Sodium chloride 0.9%
Day 0: 400-600 ml. Day 2: 200-400 ml.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886925

Contacts
Contact: Juan Cordoba, MD +34 93 274 6140 jcordoba@vhebron.net

Locations
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            
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Juan Cordoba, MD Hospital Universitari Vall d'Hebron
  More Information

No publications provided

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

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Hepatic encephalopathy
Cirrhosis
Albumin

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009