Volume Replacement Therapy during Major Orthopedic Surgery Using Voluven(R) (Hydroxyethyl Starch 130/0.4) or Hetastarch.

Author(s): Gandhi SD, Weiskopf RB, Jungheinrich C, Koorn R, Miller D, Shangraw RE, Prough DS, Baus D, Bepperling F, Warltier DC

Affiliation(s): * Assistant Professor of Anesthesiology, Department of Anesthesiology, section sign section sign Professor and Chairman of Anesthesiology and Professor of Medicine (Division of Cardiovascular Diseases) and Pharmacology and Toxicology, Department of Anesthesiology, Pharmacology and Toxicology, and Medicine (Division of Cardiovascular Diseases), Clement J. Zablocki Veterans Affairs Medical Center and the Medical College of Wisconsin, Milwaukee, Wisconsin. dagger Emeritus Professor of Anesthesiology, University of California, San Francisco, California. Dr. Weiskopf was an employee of Novo Nordisk, Bagsvaeerd, Denmark at the time of manuscript preparation. double dagger Director Medical Affairs, daggerdagger Clinical Project Manager, double daggerdouble dagger Director Preclinical and Clinical Development Pharma, Fresenius Kabi, Bad Homburg, Germany. section sign Anesthesia Associates of Southern Connecticut, Norwalk, Connecticut. parallel Professor of Anesthesiology and Perioperative Medicine, Department of Anesthesiology, Portland Veteran Affairs Medical Center, Portland, Oregon. # Professor of Anesthesiology and Perioperative Medicine, Department of Anesthesiology and Perioperative Medicine, Oregon Health and Science University, Portland, Oregon. ** Professor and Chairman of Anesthesiology, Department of Anesthesiology, University of Texas Medical Branch, Galveston, Texas.

Publication date & source: 2007-06, Anesthesiology., 106(6):1120-1127.

Publication type:

BACKGROUND:: The purpose of this study was to test the equivalence of efficacy and compare the safety of the 6% hydroxyethyl starches (HES) Voluven(R) (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). CONCLUSION:: Voluven(R) (HES 130/0.4) and hetastarch are equally efficacious plasma volume substitutes; however, HES 130/0.4 has a lesser effect on coagulation.