title: Effects of citrate acid concentrate (citrasate®) on heparin N requirements and hemodialysis adequacy: a multicenter, prospective noninferiority trial.
abstract: BACKGROUND
  Citrasate®, citric acid dialysate (CD), contains 2.4 mEq of citric acid (citrate), instead of acetic acid (acetate) as in standard bicarbonate dialysate. Previous studies suggest CD may improve dialysis adequacy and decrease heparin requirements, presumably due to nonsystemic anticoagulant effects in the dialyzer.
  
  
  METHODS
  We prospectively evaluated 277 hemodialysis patients in eight outpatient facilities to determine if CD with reduced heparin N (HN) would maintain dialyzer clearance. Subjects progressed through four study periods [baseline (B): bicarbonate dialysate + 100% HN; period 1 (P1): CD + 100% HN; period 2 (P2): CD + 80% HN; period 3 (P3): CD + 66.7% HN]. The predefined primary endpoint was noninferiority (margin -8%) of the percent change in mean dialyzer conductivity clearance between baseline and P2.
  
  
  RESULTS
  Subjects were 57.4% male, 41.7% white, 54.3% black, and 44.4% diabetic; mean age was 59 ± 14.4 years; mean time on dialysis was 1,498 ± 1,165 days; 65.7% had arteriovenous fistula, 19.9% arteriovenous graft, 14.4% catheters, and 27.8% used antiplatelet agents. Mean dialyzer clearance increased 0.9% (P1), 1.0% (P2), and 0.9% (P3) with CD despite heparin reduction. SpKt/V remained stable (B: 1.54 ± 0.29; P1: 1.54 ± 0.28; P2: 1.55 ± 0.27; P3: 1.54 ± 0.26). There was no significant difference in dialyzer/dialysis line thrombosis, post-HD time to hemostasis, percent of subjects with adverse events (AEs), or study-related AEs.
  
  
  CONCLUSIONS
  CD was safe, effective, and met all study endpoints. Dialyzer clearance increased approximately 1% with CD despite 20-33% heparin reduction. Over 92% of P3 subjects demonstrated noninferiority of dialyzer clearance with CD and 33% HN reduction. There was no significant difference in dialyzer clotting, bleeding, or adverse events.
authors.affiliation: Fresenius Medical Care North America, Celebration, FL 34747, USA. jeffrey.sands@fmc-na.com
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Sands
authors.forename: Peter
authors.initials: P
authors.lastname: Kotanko
authors.forename: Jonathan H
authors.initials: JH
authors.lastname: Segal
authors.forename: Chiang-Hong
authors.initials: CH
authors.lastname: Ho
authors.forename: Len
authors.initials: L
authors.lastname: Usvat
authors.forename: Amy
authors.initials: A
authors.lastname: Young
authors.forename: Mary
authors.initials: M
authors.lastname: Carter
authors.forename: Olga
authors.initials: O
authors.lastname: Sergeyeva
authors.forename: Lisa
authors.initials: L
authors.lastname: Korth
authors.forename: Eileen
authors.initials: E
authors.lastname: Maunsell
authors.forename: Yueping
authors.initials: Y
authors.lastname: Zhu
authors.forename: Mahesh
authors.initials: M
authors.lastname: Krishnan
authors.forename: Jose A
authors.initials: JA
authors.lastname: Diaz-Buxo
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D019343:Citric Acid / Q000627:therapeutic use*; D015314:Dialysis Solutions / Q000627:therapeutic use*; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects / Q000379:methods*
chemical_list: D000925:Anticoagulants; D015314:Dialysis Solutions; D019343:Citric Acid; D006493:Heparin