Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis

Hepatic Encephalopathy Clinical Trial

— ALFAE  

Official title:

Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886925
• Other study ID #: ALFAE
• Secondary ID: 2008-003376-21PI
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2009
• Last updated: December 14, 2012
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2012
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Albumin
Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
• Sodium chloride 0.9%
Day 0: 400-600 ml. Day 2: 200-400 ml.

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients without hepatic encephalopathy		Day 3	No
Secondary	Severity of encephalopathy assessed by CHESS and West-Haven		Admission to the hospital (up to day 14)	No