Skip to main content
OpenTrials
Completed

NCT Number: NCT00886925

Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Parc Tauli, Sabadell, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ALBUMIN

Drug

Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.

Sodium chloride 0.9%

Drug

Day 0: 400-600 ml. Day 2: 200-400 ml.

Primary outcomes

  1. Proportion of patients without hepatic encephalopathy

    Time frame: Day 3

Secondary outcomes

  1. Severity of encephalopathy assessed by CHESS and West-Haven

    Time frame: Admission to the hospital (up to day 14)

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: ALFAE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2009
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.