The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

Nobutada Morioka,Hiroshi Morimatsu,Michiaki Yamakage,Kiyoshi Morita,Frank Bepperling,Akiyoshi Namiki,Yasuyuki Suzuki,Makoto Ozaki,Hideki Miyao

doi:10.4236/ojanes.2013.37071

Abstract

Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven&#174) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4; for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.

Highlights

Colloid solutions are indicated for the treatment of hypovolemia and to maintain adequate circulating blood volume in patients undergoing surgery, experiencing trauma, or in intensive care
The study results indicate that 6% hydroxyethyl starch (HES) 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery
For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 ml/kg) albumin was saved, whereas 3 adult patients did not receive more than 1000 mL of 6% HES 130/0.4

Summary

Introduction

Colloid solutions are indicated for the treatment of hypovolemia and to maintain adequate circulating blood volume in patients undergoing surgery, experiencing trauma, or in intensive care. Among the available synthetic colloids, hydroxyethyl starch (HES) has been shown to have the lowest incidence of anaphylactoid reactions [1]. With the latest third generation, so called tetrastarches or HES 130/0.4, a major advancement in respect of safety issues has been achieved over recent years. This advancement leads to a more rapid metabolization and degradation of HES molecules and to a minimal plasma accumulation even after repeated administration of HES 130/0.4 [2].

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