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Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00886925
Acronym
ALFAE
Enrollment
56
Registered
2009-04-23
Start date
2009-03-31
Completion date
2012-07-31
Last updated
2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathy, Cirrhosis, Albumin

Brief 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.

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.

Interventions

DRUGAlbumin

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

DRUGSodium chloride 0.9%

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

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Proportion of patients without hepatic encephalopathyDay 3

Secondary

MeasureTime frame
Severity of encephalopathy assessed by CHESS and West-HavenAdmission to the hospital (up to day 14)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026