title: First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis.
abstract: BACKGROUND
  Liver failure (LF) is associated with prolonged hospital stay, increased cost and substantial mortality. Due to the limited number of donor organs, extracorporeal liver support is suggested as an appealing concept to "bridge to transplant" or to avoid transplant in case of recovery. ADVanced Organ Support (ADVOS) is a new type of albumin dialysis, that provides rapid regeneration of toxin-binding albumin by two purification circuits altering the binding capacities of albumin by biochemical (changing of pH) and physical (changing of temperature) modulation of the dialysate. It was the aim of this study to evaluate feasibility, efficacy and safety of ADVOS in the first 14 patients ever treated with this procedure.
  
  
  METHODS
  Patients included suffered from acute on chronic LF (n = 9) or "secondary" LF (n = 5) which resulted from non-hepatic diseases such as sepsis. The primary endpoint was the change of serum bilirubin, creatinine and serum BUN levels before and after the first treatment with ADVOS. The Wilcoxon Signed Rank test for paired samples was used to analyze the data.
  
  
  RESULTS
  A total of 239 treatments (1 up to 101 per patient) were performed in 14 patients (6 female, 8 male). Mean age 54 ± 13; MELD-score 34 ± 7; CLIF-SOFA 15 ± 3. Serum bilirubin levels were significantly decreased by 32% during the first session (26.0 ± 15.4 vs. 17.7 ± 10.5 mg/dl; p = 0.001). Similarly, serum creatinine (2.2 ± 0.8 vs. 1.6 ± 0.7 mg/dl; p = 0.005) and serum BUN (49.4 ± 23.3 vs. 31.1 ± 19.7 mg/dl; p = 0.003), were significantly lowered by 27% and 37%, respectively. None of the treatment sessions had to be interrupted due to side effects related to the procedure.
  
  
  CONCLUSIONS
  ADVOS efficiently eliminates water- and protein-bound toxins in humans with LF. ADVOS is feasible in patients with advanced LF which is emphasized by a total number of more than 100 treatment sessions in one single patient.
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, D-81675, Munich, Germany. Wolfgang.Huber@lrz.tum.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Huber
authors.affiliation: Klinik für Anaesthesiologie der Universität München, Campus Großhadern, Marchioninistraße, 15 81377, Munich, Germany.
authors.forename: Benedikt
authors.initials: B
authors.lastname: Henschel
authors.affiliation: II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Ismaninger Straße 22, D-81675, Munich, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Schmid
authors.affiliation: Jamaica Hospital Medical Center, 8900 Van Wyck Expy, Jamaica, NY, 11418, USA.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Al-Chalabi
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins; D015314:Dialysis Solutions; D005240:Feasibility Studies; D005260:Female; D006464:Hemoperfusion / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D017093:Liver Failure / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D015314:Dialysis Solutions
keywords: Acute liver failure; Acute-on-chronic-liver failure; CLIF-SOFA; Chronic liver failure; Extracorporeal liver support; Fractionated plasma separation and adsorption; Liver transplantation; MELD; Molecular Adsorbent Recirculating System; Single pass albumin dialysis