title: Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study.
abstract: OBJECTIVE
  Episodic hepatic encephalopathy is frequently precipitated by factors that induce circulatory dysfunction, cause oxidative stress-mediated damage or enhance astrocyte swelling. The administration of albumin could modify these factors and improve the outcome of hepatic encephalopathy. The aim of this study is to assess the efficacy of albumin in a multicenter, prospective, double-blind, controlled trial (ClinicalTrials.gov number, NCT00886925).
  
  
  METHODS
  Cirrhotic patients with an acute episode of hepatic encephalopathy (grade II-IV) were randomized to receive albumin (1.5g/kg on day 1 and 1.0g/kg on day 3) or isotonic saline, in addition to the usual treatment (laxatives, rifaximin 1200mg per day). The primary end point was the proportion of patients in which encephalopathy was resolved on day 4. The secondary end points included survival, length of hospital stay, and biochemical parameters.
  
  
  RESULTS
  Fifty-six patients were randomly assigned to albumin (n=26) or saline (n=30) stratified by the severity of HE. Both groups were comparable regarding to demographic data, liver function, and precipitating factors. The percentage of patients without hepatic encephalopathy at day 4 did not differ between both groups (albumin: 57.7% vs. saline: 53.3%; p>0.05). However, significant differences in survival were found at day 90 (albumin: 69.2% vs. saline: 40.0%; p=0.02).
  
  
  CONCLUSIONS
  Albumin does not improve the resolution of hepatic encephalopathy during hospitalization. However, differences in survival after hospitalization suggest that the development of encephalopathy may identify a subgroup of patients with advanced cirrhosis that may benefit from the administration of albumin.
authors.affiliation: Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Macarena
authors.initials: M
authors.lastname: Simón-Talero
authors.forename: Rita
authors.initials: R
authors.lastname: García-Martínez
authors.forename: Maria
authors.initials: M
authors.lastname: Torrens
authors.forename: Salvador
authors.initials: S
authors.lastname: Augustin
authors.forename: Susana
authors.initials: S
authors.lastname: Gómez
authors.forename: Gustavo
authors.initials: G
authors.lastname: Pereira
authors.forename: Mónica
authors.initials: M
authors.lastname: Guevara
authors.forename: Pere
authors.initials: P
authors.lastname: Ginés
authors.forename: Germán
authors.initials: G
authors.lastname: Soriano
authors.forename: Eva
authors.initials: E
authors.lastname: Román
authors.forename: Jordi
authors.initials: J
authors.lastname: Sánchez-Delgado
authors.forename: Roser
authors.initials: R
authors.lastname: Ferrer
authors.forename: Juan C
authors.initials: JC
authors.lastname: Nieto
authors.forename: Pilar
authors.initials: P
authors.lastname: Sunyé
authors.forename: Inma
authors.initials: I
authors.lastname: Fuentes
authors.forename: Rafael
authors.initials: R
authors.lastname: Esteban
authors.forename: Juan
authors.initials: J
authors.lastname: Córdoba
mesh_terms: D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006501:Hepatic Encephalopathy / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007275:Injections, Intravenous; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000418:Albumins
keywords: ACLF; ALB; Albumin; CHESS; Cirrhosis; HE; HESA; Hepatic encephalopathy; Human; IL; MDA; MELD; Model for End-Stage Liver Disease; SAL; TNF-α; Treatment; acute-on-chronic liver failure; albumin group; clinical hepatic encephalopathy staging scale; hepatic encephalopathy; hepatic encephalopathy scoring algorithm; interleukin; malondialdehyde; saline group; tumor necrosis factor alpha