ALFAE: Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00886925

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: Albumin Drug: Sodium chloride 0.9%	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albumin	Drug: Albumin Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.
Placebo Comparator: Saline	Drug: Sodium chloride 0.9% Day 0: 400-600 ml. Day 2: 200-400 ml.

Arm

Intervention/Treatment

Active Comparator: Albumin

Drug: Albumin

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

Placebo Comparator: Saline

Drug: Sodium chloride 0.9%

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

Outcome Measures

Primary Outcome Measures

Proportion of patients without hepatic encephalopathy [Day 3]

Secondary Outcome Measures

Severity of encephalopathy assessed by CHESS and West-Haven [Admission to the hospital (up to day 14)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parc Tauli	Sabadell	Barcelona	Spain
2	Hospital de Sant Pau	Barcelona		Spain	08025
3	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
4	Hospital Clinic	Barcelona		Spain	08036