title: Albumin dialysis with a noncell artificial liver support device in patients with acute liver failure: a randomized, controlled trial.
abstract: BACKGROUND
  Albumin dialysis with the Molecular Adsorbent Recirculating System (MARS) (Gambro, Lund, Sweden), a noncell artificial liver support device, may be beneficial in acute liver failure (ALF).
  
  
  OBJECTIVE
  To determine whether MARS improves survival in ALF.
  
  
  METHODS
  Randomized, controlled trial. (ClinicalTrials.gov: NCT00224705).
  
  
  METHODS
  16 French liver transplantation centers.
  
  
  METHODS
  102 patients with ALF.
  
  
  METHODS
  Conventional treatment (n = 49) or MARS with conventional treatment (n = 53), stratified according to whether paracetamol caused ALF.
  
  
  METHODS
  6-month survival and secondary end points, including adverse events.
  
  
  RESULTS
  102 patients (mean age, 40.4 years [SD, 13]) were in the modified intention-to-treat (mITT) population. The per-protocol analysis (49 conventional, 39 MARS) included patients with at least 1 session of MARS of 5 hours or more. Six-month survival was 75.5% (95% CI, 60.8% to 86.2%) with conventional treatment and 84.9% (CI, 71.9% to 92.8%) with MARS (P = 0.28) in the mITT population and 75.5% (CI, 60.8% to 86.2%) with conventional treatment and 82.9% (CI, 65.9% to 91.9%) with MARS (P = 0.50) in the per-protocol population. In patients with paracetamol-related ALF, the 6-month survival rate was 68.4% (CI, 43.5% to 86.4%) with conventional treatment and 85.0% (CI, 61.1% to 96.0%) with MARS (P = 0.46) in the mITT population. Sixty-six of 102 patients had transplantation (41.0% among paracetamol-induced ALF; 79.4% among non-paracetamol-induced ALF) (P < 0.001). Adverse events did not significantly differ between groups.
  
  
  CONCLUSIONS
  The short delay from randomization to liver transplantation (median, 16.2 hours) precludes definitive efficacy or safety evaluations.
  
  
  CONCLUSIONS
  This randomized trial of MARS in patients with ALF was unable to provide definitive efficacy or safety conclusions because many patients had transplantation before administration of the intervention. Acute liver failure not caused by paracetamol was associated with greater 6-month patient survival.
  
  
  BACKGROUND
  Assistance Publique-Hôpitaux de Paris.
authors.forename: Faouzi
authors.initials: F
authors.lastname: Saliba
authors.forename: Christophe
authors.initials: C
authors.lastname: Camus
authors.forename: François
authors.initials: F
authors.lastname: Durand
authors.forename: Philippe
authors.initials: P
authors.lastname: Mathurin
authors.forename: Alexia
authors.initials: A
authors.lastname: Letierce
authors.forename: Bertrand
authors.initials: B
authors.lastname: Delafosse
authors.forename: Karl
authors.initials: K
authors.lastname: Barange
authors.forename: Pierre François
authors.initials: PF
authors.lastname: Perrigault
authors.forename: Magali
authors.initials: M
authors.lastname: Belnard
authors.forename: Philippe
authors.initials: P
authors.lastname: Ichaï
authors.forename: Didier
authors.initials: D
authors.lastname: Samuel
mesh_terms: D000328:Adult; D000418:Albumins; D005260:Female; D006501:Hepatic Encephalopathy / Q000628:therapy; D006801:Humans; D057194:Intention to Treat Analysis; D007677:Kidney Function Tests; D017114:Liver Failure, Acute / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008111:Liver Function Tests; D016031:Liver Transplantation; D019164:Liver, Artificial / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000418:Albumins