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CARDIOVASCULAR ANESTHESIA

Hydroxyethyl Starch in Balanced Electrolyte Solution (Hextend^®)—Pharmacokinetic and Pharmacodynamic Profiles in Healthy Volunteers

Nicholas J. Wilkes, MD^*, Rex L. Woolf, MD^*, Michael C. Powanda, Tong J. Gan, MD, Sam J. Machin, MD, Andrew Webb, MD^*, Marjorie Mutch, RGN^*, Elliott Bennett-Guerrero, MD, and Michael Mythen, MD^*

*Centre for Anaesthesia, Royal Free and University College London School of Medicine, London, UK; Duke University, Durham, North Carolina; Department of Haematology, University College London Hospitals, London, UK; and The Mount Sinai School of Medicine, New York, New York

Address correspondence and reprint requests to Nicholas Wilkes, MD, Centre for Anaesthesia, Royal Free and University College London School of Medicine, Room 103, First Floor Crosspiece, Middlesex Hospital, Mortimer Street, London W1N 8AA. Address e-mail to Nicholas.Wilkes{at}rfh.nthames.nhs.uk

Hextend^® is a new plasma volume expander containing 6% hydroxyethyl starch (HES) in a physiologically balanced medium of electrolytes, glucose, and lactate (weight average, molecular weight 670 kDa, molar substitution 0.75). This open-label study was designed to investigate the pharmacokinetic and pharmacodynamic profiles of Hextend^® in 21 healthy volunteers. We infused Hextend^® 10 ml/kg IV over 20 min and determined serum concentrations of HES at selected intervals over a 7-day period. Serum concentration-time curves indicated mixed pharmacokinetic behavior reflecting a two-compartment model in most subjects. The median serum half-life over 7 days was 38.2 h. The balanced formulation of the suspension medium did not seem to affect distribution, metabolism, or excretion of Hextend^® when compared with similar HES. Pharmacodynamic analysis demonstrated decreases in some plasma components compatible with the infusion of that volume of fluid and the duration of plasma volume expansion. Other plasma components remained unchanged, reflecting the benefit of a balanced electrolyte solution. Hemodilution was observed for 24–48 h after short-term infusion of Hextend^®. Some hemostatic indices showed moderate changes, and serum amylase demonstrated a temporary increase. Our study suggested that Hextend^® has pharmacokinetic and pharmacodynamic profiles that are similar to those of other HES.

IMPLICATIONS: Hextend^® is a new plasma volume expander containing 6% hydroxyethyl starch in a physiologically balanced medium. This open-label volunteer study demonstrated that it has pharmacokinetic and pharmacodynamic profiles similar to those of established HES.

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