Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis

NCT ID: NCT00886925

Last Updated: 2012-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathy; Cirrhosis; Albumin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Albumin

Group Type: ACTIVE_COMPARATOR

Albumin

Intervention Type: DRUG

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

Saline

Group Type: PLACEBO_COMPARATOR

Sodium chloride 0.9%

Intervention Type: DRUG

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

Interventions

Albumin

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

Intervention Type: DRUG

Sodium chloride 0.9%

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Cordoba, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

Parc Tauli

Sabadell, Barcelona, Spain

Hospital de Sant Pau

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clinic

Barcelona, , Spain

Countries

Spain

References

Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.

Reference Type: DERIVED

PMID: 23872605 (View on PubMed)

Other Identifiers

2008-003376-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI07 - 0641

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ALFAE

Identifier Type: -

Identifier Source: org_study_id