Volume replacement therapy during major orthopedic surgery using Voluven (hydroxyethyl starch 130/0.4) or hetastarch.
BACKGROUND
The purpose of this study was to test the equivalence of efficacy and compare the safety of the 6% hydroxyethyl starches (HES) Voluven (HES 130/0.4; Fresenius Kabi, Bad Homburg, Germany) and hetastarch (HES 670/0.75 in saline) for intravascular volume replacement therapy during major orthopedic surgery.


METHODS
In a prospective, controlled, randomized, double-blind, multicenter trial of patients undergoing major orthopedic surgery, 49 patients were treated with HES 130/0.4 and 51 patients were treated with hetastarch. Infusion of colloids was guided by central venous and arterial blood pressures. The primary efficacy endpoint was the volume of colloid solution infused; the primary safety endpoints were calculated total erythrocyte loss, the nadir factor VIII activity, and the nadir von Willebrand factor concentration within 2 h of completion of surgery.


RESULTS
The total volume of colloid solution required for intraoperative volume replacement did not differ between HES 130/0.4 and hetastarch (1,613+/-778 [SD] ml for HES 130/0.4 and 1,584+/-958 ml for hetastarch). The nadir factor VIII activity within 2 h of the end of surgery was lower for hetastarch than for HES 130/0.4 (P=0.0499); for those who received greater than 1,000 ml colloid, the nadir factor VIII activity and von Willebrand factor concentration within 2 h of end of surgery were lower for hetastarch than for HES 130/0.4 (P=0.0487 and P=0.008, respectively).


CONCLUSIONS
Voluven (HES 130/0.4) and hetastarch are equally efficacious plasma volume substitutes; however, HES 130/0.4 has a lesser effect on coagulation.
Gandhi
Sweeta D
SD
Department of Anesthesiology, Clement J. Zablocki Veterans Affairs Medical Center and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, USA. sdgandhi@mcw.edu
Weiskopf
Richard B
RB
Jungheinrich
Cornelius
C
Koorn
Robert
R
Miller
Diane
D
Shangraw
Robert E
RE
Prough
Donald S
DS
Baus
Daniela
D
Bepperling
Frank
F
Warltier
David C
DC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000187:drug effects*; D001810:Blood Volume; D004311:Double-Blind Method; D005169:Factor VIII / Q000378:metabolism; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000627:therapeutic use*; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures; D010952:Plasma Substitutes / Q000627:therapeutic use*
C485123:HES 130-0.4; D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D005169:Factor VIII