title: A comparison of the potential for acute cardiopulmonary adverse effects in dogs during continuous veno-venous hemofiltration with accusol 35 solution with and without induced calcium carbonate particles.
abstract: BACKGROUND
  Baxter received reports of visible precipitate, identified as calcium carbonate, forming during hemofiltration with Accusol 35 solution.
  
  
  OBJECTIVE
  To evaluate the potential for acute cardiopulmonary adverse effects of Accusol 35 containing exaggerated calcium carbonate particles.
  
  
  METHODS
  Anesthetized dogs underwent continuous veno-venous hemofiltration (CVVH) with Accusol 35 containing visible and subvisible particles (≥10 µm) 36 times higher than the maximum concentration specified in the European Pharmacopoeia (P-Accusol), or Accusol 35 conforming to specification (Accusol). Select cardiovascular and blood gas parameters were evaluated during CVVH. Lung tissue samples were collected following CVVH.
  
  
  RESULTS
  No differences were observed in cardiovascular and blood gas parameters or lung histology between P-Accusol and Accusol.
  
  
  CONCLUSIONS
  Accusol 35 containing visible and subvisible particles (≥10 µm) 36 times higher than the maximum concentration specified in the European Pharmacopoeia resulted in no acute cardiopulmonary adverse effects compared with Accusol 35 containing no visible particles and subvisible particles within European Pharmacopoeia specification.
authors.affiliation: Baxter Healthcare Corporation (BHC), Round Lake, Ill., USA.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: McKee
authors.forename: Benjamin D
authors.initials: BD
authors.lastname: Brooks
authors.forename: Justin R
authors.initials: JR
authors.lastname: Daller
authors.forename: Joseph
authors.initials: J
authors.lastname: Safron
authors.forename: Jerome H
authors.initials: JH
authors.lastname: Gass
authors.forename: David P
authors.initials: DP
authors.lastname: Pantaleone
authors.forename: Paul A
authors.initials: PA
authors.lastname: Zieske
authors.forename: Paola
authors.initials: P
authors.lastname: Mussi
authors.forename: Benoit
authors.initials: B
authors.lastname: Moreaux
mesh_terms: D000818:Animals; D002119:Calcium Carbonate / Q000737:chemistry*; D003460:Crystallization; D004285:Dogs; D006335:Heart Injuries / Q000209:etiology*; D015312:Hemodialysis Solutions / Q000009:adverse effects* / Q000737:chemistry*; D006440:Hemofiltration / Q000009:adverse effects* / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D055370:Lung Injury / Q000209:etiology* / Q000473:pathology; D008297:Male; D023421:Models, Animal; D010316:Particle Size
chemical_list: D015312:Hemodialysis Solutions; D002119:Calcium Carbonate