title: The effects of biocompatible compared with standard peritoneal dialysis solutions on peritonitis microbiology, treatment, and outcomes: the balANZ trial.
abstract: BACKGROUND
  A multicenter, multi-country randomized controlled trial (the balANZ study) recently reported that peritonitis rates significantly improved with the use of neutral-pH peritoneal dialysis (PD) solutions low in glucose degradation products ("biocompatible") compared with standard solutions. The present paper reports a secondary outcome analysis of the balANZ trial with respect to peritonitis microbiology, treatment, and outcomes.
  
  
  METHODS
  Adult incident PD patients with residual renal function were randomized to receive either biocompatible or conventional (control) PD solutions for 2 years.
  
  
  RESULTS
  The safety population analysis for peritonitis included 91 patients in each group. The unadjusted geometric mean peritonitis rates in those groups were 0.30 [95% confidence interval (CI): 0.22 to 0.41] episodes per patient-year for the biocompatible group and 0.49 (95% CI: 0.39 to 0.62) episodes per patient-year for the control group [incidence rate ratio (IRR): 0.61; 95% CI: 0.41 to 0.90; p = 0.01]. When specific causative organisms were examined, the rates of culture-negative, gram-positive, gram-negative, and polymicrobial peritonitis episodes were not significantly different between the biocompatible and control groups, although the biocompatible group did experience a significantly lower rate of non-pseudomonal gram-negative peritonitis (IRR: 0.41; 95% CI: 0.18 to 0.92; p = 0.03). Initial empiric antibiotic regimens were comparable between the groups. Biocompatible fluid use did not significantly reduce the risk of peritonitis-associated hospitalization (adjusted odds ratio: 0.80; 95% CI: 0.48 to 1.34), but did result in a shorter median duration of peritonitis-associated hospitalization (6 days vs 11 days, p = 0.05). Peritonitis severity was more likely to be rated as mild in the biocompatible group (37% vs 10%, p = 0.001). Overall peritonitis-associated technique failures and peritonitis-related deaths were comparable in the two groups.
  
  
  CONCLUSIONS
  Biocompatible PD fluid use was associated with a broad reduction in gram-positive, gram-negative, and culture-negative peritonitis that reached statistical significance for non-pseudomonal gram-negative organisms. Peritonitis hospitalization duration was shorter, and peritonitis severity was more commonly rated as mild in patients receiving biocompatible PD fluids, although other peritonitis outcomes were comparable between the groups.
authors.affiliation: Department of Nephrology, University of Queensland, Brisbane, Australia. david_johnson@health.qld.gov.au
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.forename: Fiona G
authors.initials: FG
authors.lastname: Brown
authors.forename: Margaret
authors.initials: M
authors.lastname: Clarke
authors.forename: Neil
authors.initials: N
authors.lastname: Boudville
authors.forename: Tony J
authors.initials: TJ
authors.lastname: Elias
authors.forename: Marjorie W Y
authors.initials: MW
authors.lastname: Foo
authors.forename: Bernard
authors.initials: B
authors.lastname: Jones
authors.forename: Hemant
authors.initials: H
authors.lastname: Kulkarni
authors.forename: Robyn
authors.initials: R
authors.lastname: Langham
authors.forename: Dwarakanathan
authors.initials: D
authors.lastname: Ranganathan
authors.forename: John
authors.initials: J
authors.lastname: Schollum
authors.forename: Michael G
authors.initials: MG
authors.lastname: Suranyi
authors.forename: Seng H
authors.initials: SH
authors.lastname: Tan
authors.forename: David
authors.initials: D
authors.lastname: Voss
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents; D001315:Australia; D001672:Biocompatible Materials / Q000494:pharmacology*; D015314:Dialysis Solutions / Q000737:chemistry / Q000494:pharmacology*; D005260:Female; D006760:Hospitalization; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007676:Kidney Failure, Chronic / Q000150:complications / Q000382:microbiology / Q000628:therapy*; D008297:Male; D009520:New Zealand; D010530:Peritoneal Dialysis / Q000009:adverse effects / Q000379:methods*; D010537:Peritoneum / Q000187:drug effects / Q000382:microbiology*; D010538:Peritonitis / Q000188:drug therapy / Q000453:epidemiology / Q000382:microbiology*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D001672:Biocompatible Materials; D015314:Dialysis Solutions