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

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: Sodium chloride 0.9%; Drug: Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT00886925

PI07 - 0641 (Other Grant/Funding Number)

2008-003376-21 (EudraCT Number)

ALFAE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Albumin

Active Comparator group

Treatment:

Drug: Albumin

Saline

Placebo Comparator group

Treatment:

Drug: Sodium chloride 0.9%