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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886925
First Posted: April 23, 2009
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Severity of encephalopathy assessed by CHESS and West-Haven [ Time Frame: Admission to the hospital (up to day 14) ]

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

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886925


Locations
Spain
Parc Tauli
Sabadell, Barcelona, Spain
Hospital de Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Juan Cordoba, MD Hospital Vall d'Hebron
  More Information

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 ( EudraCT Number )
PI07 - 0641 ( Other Grant/Funding Number: FIS (Instituto de Salud Carlos III) )
First Submitted: April 22, 2009
First Posted: April 23, 2009
Last Update Posted: December 17, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Hepatic Encephalopathy
Fibrosis
Liver Cirrhosis
Brain Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases