Journal of Hepatology
Volume 59, Issue 6 , Pages 1184-1192, December 2013
Macarena Simón-Talero, Rita García-Martínez, Maria Torrens, Salvador Augustin, Susana Gómez, Gustavo Pereira, Mónica Guevara, Pere Ginés, Germán Soriano, Eva Román, Jordi Sánchez-Delgado, Roser Ferrer, Juan C. Nieto, Pilar Sunyé, Inma Fuentes, Rafael Esteban,Juan Córdoba
Received 17 April 2013; received in revised form 4 July 2013; accepted 7 July 2013. published online 22 July 2013.
Background & Aims
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).
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.
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).
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.
Abbreviations: HE, hepatic encephalopathy, ACLF, acute-on-chronic liver failure, ALB, albumin group, SAL, saline group, CHESS, clinical hepatic encephalopathy staging scale, HESA, hepatic encephalopathy scoring algorithm, TNF-α, tumor necrosis factor alpha, IL, interleukin,MDA, malondialdehyde, MELD, Model for End-Stage Liver Disease