Liver Failure/Cirrhosis/Portal Hypertension
Article first published online: 15 FEB 2013
Copyright © 2012 American Association for the Study of Liver Diseases
Volume 57, Issue 3, pages 1153–1162, March 2013
How to Cite
Bañares, R., Nevens, F., Larsen, F. S., Jalan, R., Albillos, A., Dollinger, M., Saliba, F., Sauerbruch, T., Klammt, S., Ockenga, J., Pares, A., Wendon, J., Brünnler, T., Kramer, L., Mathurin, P., de la Mata, M., Gasbarrini, A., Müllhaupt, B., Wilmer, A., Laleman, W., Eefsen, M., Sen, S., Zipprich, A., Tenorio, T., Pavesi, M., Schmidt, H. H.-J., Mitzner, S., Williams, R., Arroyo, V. and on behalf of the RELIEF study group (2013), Extracorporeal albumin dialysis with the molecular adsorbent recirculating system in acute-on-chronic liver failure: The RELIEF trial. Hepatology, 57: 1153–1162. doi: 10.1002/hep.26185
Potential conflict of interest: Prof. Rafael Bañares received honoraria for lectures and consultancy fee by Gambro. Prof. Jalan has had research funding from Teraklin in the past and more recently has ongoing collaboration with Gambro towards development of a new device. Prof. Faouzi Saliba has received speaker's honoraria and research funding from Gambro. Dr. Dollinger is on the speakers' bureau of and received grants from Gambro. Dr. Mitzner is on the speakers' bureau of Gambro.
The study was supported by Gambro Lundia AB Sweden. CIBEREHD was funded by National Institute of Health Carlos III, Ministry of Economy Spain.
- Issue published online: 28 FEB 2013
- Article first published online: 15 FEB 2013
- Accepted manuscript online: 5 DEC 2012 12:00AM EST
- Manuscript Accepted: 3 OCT 2012
- Manuscript Received: 24 JUL 2012
Acute-on-chronic liver failure (ACLF) is a frequent cause of death in cirrhosis. Albumin dialysis with the molecular adsorbent recirculating system (MARS) decreases retained substances and improves hemodynamics and hepatic encephalopathy (HE). However, its survival impact is unknown. In all, 189 patients with ACLF were randomized either to MARS (n = 95) or to standard therapy (SMT) (n = 94). Ten patients (five per group) were excluded due to protocol violations. In addition, 23 patients (MARS: 19; SMT: 4) were excluded from per-protocol (PP) analysis (PP population n = 156). Up to 10 6-8-hour MARS sessions were scheduled. The main endpoint was 28-day ITT and PP survival. There were no significant differences at inclusion, although the proportion of patients with Model for Endstage Liver Disease (MELD) score over 20 points and with spontaneous bacterial peritonitis (SBP) as a precipitating event was almost significantly greater in the MARS group. The 28-day survival was similar in the two groups in the ITT and PP populations (60.7% versus 58.9%; 60% versus 59.2% respectively). After adjusting for confounders, a significant beneficial effect of MARS on survival was not observed (odds ratio [OR]: 0.87, 95% confidence interval [CI] 0.44-1.72). MELD score and HE at admission and the increase in serum bilirubin at day 4 were independent predictors of death. At day 4, a greater decrease in serum creatinine (P = 0.02) and bilirubin (P = 0.001) and a more frequent improvement in HE (from grade II-IV to grade 0-I; 62.5% versus 38.2%; P = 0.07) was observed in the MARS group. Severe adverse events were similar. Conclusion: At scheduled doses, a beneficial effect on survival of MARS therapy in patients with ACLF could not be demonstrated. However, MARS has an acceptable safety profile, has significant dialysis effect, and nonsignificantly improves severe HE. (HEPATOLOGY 2013)