title: Efficacy and safety of 10% HES 130/0.4 versus 10% HES 200/0.5 for plasma volume expansion in cardiac surgery patients.
abstract: OBJECTIVE
  Hydroxyethyl starch (HES) solutions are frequently used for perioperative volume replacement. Whereas older HES specimen tended to accumulate in the plasma and to cause negative effects on hemostasis, more recent products, e.g., HES 130/0.4, are characterised by improved pharmacological properties. The present study was designed to compare the efficacy and safety of 10% HES 130/0.4 and 10% HES 200/0.5.
  
  
  METHODS
  In this post-hoc analysis of a prospective, randomised, double-blind, multi-center therapeutic equivalence trial, 76 patients undergoing elective on-pump cardiac surgery received perioperative volume replacement using either 10% HES 130/0.4 (N.=37) or 10% HES 200/0.5 (N.=39) up to a maximum dose of 20 mL kg-1.
  
  
  RESULTS
  Equivalent volumes of investigational medication were infused until 24 hours after the first administration (1577 vs. 1540 mL; treatment difference 37 [-150; 223] mL; P<0.0001 for equivalence). Whereas standard laboratory tests of coagulation were comparable between groups, von Willebrand factor activity on the first postoperative morning tended to be higher following treatment with 10% HES 130/0.4 as compared to 10% HES 200/0.5 (P=0.025) with this difference being statistically significant only in the per-protocol analysis (P=0.02). Treatment groups were comparable concerning other safety parameters and the incidence of adverse drug reactions. In particular, renal function was well preserved in both groups.
  
  
  CONCLUSIONS
  Ten percent HES 130/0.4 was equally effective and safe as compared to 10% HES 200/0.5 for volume therapy in patients undergoing cardiovascular surgery. Postoperative coagulation and renal function, as measured by standard laboratory tests, were similar among groups.
authors.affiliation: Department of Anesthesiology, Intensive Care and Pain Therapy, University Hospital of Muenster Muenster, Germany. ertmerc@gmx.net
authors.forename: C
authors.initials: C
authors.lastname: Ertmer
authors.forename: H
authors.initials: H
authors.lastname: Wulf
authors.forename: H
authors.initials: H
authors.lastname: Van Aken
authors.forename: P
authors.initials: P
authors.lastname: Friederich
authors.forename: C
authors.initials: C
authors.lastname: Mahl
authors.forename: F
authors.initials: F
authors.lastname: Bepperling
authors.forename: M
authors.initials: M
authors.lastname: Westphal
authors.forename: W
authors.initials: W
authors.lastname: Gogarten
mesh_terms: D001780:Blood Coagulation Tests; D002315:Cardiopulmonary Bypass; D004311:Double-Blind Method; D005169:Factor VIII / Q000032:analysis; D005260:Female; D005858:Germany; D006351:Heart Valves / Q000601:surgery*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D010952:Plasma Substitutes / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D014841:von Willebrand Factor / Q000032:analysis
chemical_list: D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; C517718:hydroxyethylstarch 200; D014841:von Willebrand Factor; D005169:Factor VIII