Status:
COMPLETED
Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 ...
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 b...
Eligibility Criteria
Inclusion
- Cirrhosis of the liver
- Hepatic encephalopathy stage\>1
- Completion of a standardized protocol to investigate precipitating factors
- Informed consent by next of keen
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00886925
Start Date
March 1 2009
End Date
July 1 2012
Last Update
December 17 2012
Active Locations (4)
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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