TITLE:
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
AUTHORS:
Nobutada Morioka, Makoto Ozaki, Michiaki Yamakage, Hiroshi Morimatsu, Yasuyuki Suzuki, Frank Bepperling, Hideki Miyao, Akiyoshi Namiki, Kiyoshi Morita
KEYWORDS:
High Dose; Volume Effect; Safety; 6% Hydroxyethyl Starch 130/0.4; Elective Surgery; Multi-Center Study
JOURNAL NAME:
Open Journal of Anesthesiology,
Vol.3 No.7,
September
4,
2013
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®) 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.