Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis (ALFAE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00886925
First received: April 22, 2009
Last updated: December 14, 2012
Last verified: April 2012
  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 4

Study Type: Interventional
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.

Resource links provided by NLM:


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 ]

Enrollment: 56
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Albumin Drug: 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.

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

Locations
Spain
Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic
Barcelona, Spain, 08036
Hospital de Sant Pau
Barcelona, Spain, 08025
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 by Hospital Universitari Vall d'Hebron Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT00886925     History of Changes
Other Study ID Numbers: ALFAE, 2008-003376-21, PI07 - 0641
Study First Received: April 22, 2009
Last Updated: December 14, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Hepatic Encephalopathy
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 17, 2014