title: Efficacy and safety of hydroxyethyl starch 6% 130/0.4 in a balanced electrolyte solution (Volulyte) during cardiac surgery.
abstract: OBJECTIVE
  The infusion of large amounts of saline-based solutions may contribute to the development of hyperchloremic metabolic acidosis and the use of a balanced carrier for colloid solutions might improve postoperative acid-base status. The equivalence of 2 hydroxyethyl starch (HES) solutions and the influence on chloride levels and acid-base status by selectively changing the carrier of rapidly degradable modern 6% HES 130/0.4 were studied in cardiac surgery patients.
  
  
  METHODS
  A prospective, randomized, double-blinded study.
  
  
  METHODS
  A clinical study in 2 cardiac surgery institutions.
  
  
  METHODS
  Eighty-one patients.
  
  
  METHODS
  Patients received either 6% HES130/0.4 balanced (Volulyte; Fresenius Kabi, Bad Homburg, Germany) or 6% HES130/0.4 saline (Voluven; Fresenius Kabi, Bad Homburg, Germany) for intra- and postoperative hemodynamic stabilization.
  
  
  RESULTS
  The therapeutic equivalence of both HES formulations regarding volume effect and superiority of the balanced electrolyte solution regarding serum chloride levels and acid-base status were measured. Similar volumes of both HES 130/0.4 balanced and HES 130/0.4 saline were administered until 6 hours after surgery, 2,391 ± 518 mL in the HES 130/0.4 balanced group versus 2,241 ± 512 mL in the HES 130/0.4 saline group. The 95% confidence interval for the difference between treatments (-77; 377 mL; mean, 150 mL) was contained entirely in the predefined interval (-500, 500 mL), thereby proving equivalence. The serum chloride level (mmol/L) was lower (p < 0.05 at the end of surgery), and arterial pH was higher in the balanced group at all time points except baseline, and base excess was less negative at all time points after baseline (p < 0.01).
  
  
  CONCLUSIONS
  Volumes of HES needed for hemodynamic stabilization were equivalent between treatment groups. Significantly lower serum chloride levels in the HES balanced group reflected the lower chloride load of similar infusion volumes. The HES balanced group had significantly less acidosis.
authors.affiliation: Department of Anesthesiology & Intensive Care Medicine, Medical University, Vienna, Austria. eva.base@meduniwien.ac.at
authors.forename: Eva M
authors.initials: EM
authors.lastname: Base
authors.forename: Thomas
authors.initials: T
authors.lastname: Standl
authors.forename: Andrea
authors.initials: A
authors.lastname: Lassnigg
authors.forename: Keso
authors.initials: K
authors.lastname: Skhirtladze
authors.forename: Cornelius
authors.initials: C
authors.lastname: Jungheinrich
authors.forename: Daniela
authors.initials: D
authors.lastname: Gayko
authors.forename: Michael
authors.initials: M
authors.lastname: Hiesmayr
mesh_terms: D000137:Acid-Base Imbalance / Q000097:blood / Q000517:prevention & control; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001784:Blood Gas Analysis / Q000379:methods; D006348:Cardiac Surgical Procedures / Q000379:methods; D002712:Chlorides / Q000097:blood; D004311:Double-Blind Method; D004573:Electrolytes / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D007430:Intraoperative Care / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D019999:Pharmaceutical Solutions / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D010952:Plasma Substitutes / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D002712:Chlorides; D004573:Electrolytes; C485123:HES 130-0.4; D006895:Hydroxyethyl Starch Derivatives; D019999:Pharmaceutical Solutions; D010952:Plasma Substitutes