Clinical trial NCT00886925: Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis
Official title: Effects of the Administration of Albumin in Patients With Cirrhosis and Acute Hepatic Encephalopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: Hepatic encephalopathy
Cirrhosis
Albumin
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Proportion of patients without hepatic encephalopathy
timeFrame: Day 3
Secondary outcomes:
measure: Severity of encephalopathy assessed by CHESS and West-Haven
timeFrame: Admission to the hospital (up to day 14)
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Vall d'Hebron
name: Juan Cordoba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.