title: A randomized cross-over study comparing the performance of HD integra™ central concentrate system versus pre-produced concentrate in hemodialysis.
abstract: Pre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption.
  
  
  
  We conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting.
  
  
  
  Microbial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%.
  
  
  
  Modern CCS is bacteriologically safe and its performance statistically equivalent to PPC.
authors.affiliation: Ipoh Specialist Hospital, Ipoh, Malaysia.
authors.forename: K
authors.initials: K
authors.lastname: Fauziah
authors.affiliation: Ipoh Specialist Hospital, Ipoh, Malaysia.
authors.forename: K W
authors.initials: KW
authors.lastname: Go
authors.affiliation: Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.
authors.forename: A
authors.initials: A
authors.lastname: Ghazali
authors.affiliation: International Medical University, Kuala Lumpur, Malaysia.
authors.forename: M
authors.initials: M
authors.lastname: Zaki
authors.affiliation: International Medical University, Kuala Lumpur, Malaysia. limteckonn@gmail.com.
authors.forename: T O
authors.initials: TO
authors.lastname: Lim
mesh_terms: D001639:Bicarbonates / Q000032:analysis; D002712:Chlorides / Q000032:analysis; D018592:Cross-Over Studies; D015312:Hemodialysis Solutions / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008296:Malaysia; D006435:Renal Dialysis / Q000379:methods*; D012964:Sodium / Q000032:analysis
chemical_list: D001639:Bicarbonates; D002712:Chlorides; D015312:Hemodialysis Solutions; D012964:Sodium
keywords: Central concentrate system; Chronic kidney disease; Concentrate; Dialysate; Dialysis; Dialysis fluid