To the Editor:
Kancir et al.1 are to be commended for conducting a properly powered double-blind trial examining the renal effects of hydroxyethyl starch 130/0.4 in orthopedic surgery. The presented data and analyses are very instructive. An additional edifying analysis (it could have been the primary analysis) would be a comparison of the two groups (hydroxyethyl starch and NaCl) for the changes from baseline to the last data point (“follow-up”) for urine neutrophil gelatinase- associated lipocalin activity and creatinine clearance. Although there were no differences between the groups for the absolute values at these time points, the relative changes from baseline are of greater clinical interest, and for urinary neutrophil gelatinase-associated lipocalin (the primary outcome measure), the groups moved in opposite directions.
The author has a relationship with or consults for the following companies and organizations that have an interest in intravenous fluid therapy: U.S. Food and Drug Administration (Bethesda, Maryland); U.S. National Heart, Lung, and Blood Institute/National Institutes of Health (Bethesda, Maryland); U.S. Department of Defense (Frederick, Maryland); TerumoBCT (Lakewood, Colorado); HbO2 Therapeutics (Souderton, Pennsylvania); and Octapharma USA (Hoboken, New Jersey). The author helped design a multicenter clinical trial (Gandhi SD, Weiskopf RB, Jungheinrich C, Koorn R, Miller D, Shangraw RE, Prough DS, Baus D, Bepperling F, Warltier DC: Volume replacement therapy during major orthopedic surgery using Voluven (hydroxyethyl starch 130/0.4) or a hetastarch. Anesthesiology 2007; 106:1120–7) sponsored by Fresenius-Kabi (Bad Homburg, Germany), participated in a review of tetrastarches (Van Der Linden P, James M, Mythen M, Weiskopf RB: Safety of modern starches used during surgery. Anesth Analg 2013; 116:35–48), and has received reimbursements for travel expenses and honoraria from Fresenius-Kabi for presentations. In the past, the author has consulted for the following companies that had an interest in development of hemoglobin-based oxygen carriers: Somatogen (Boulder, Colorado), Hemosol (Mississauga, Ontario, Canada), Sangart (San Diego, California), and OPK Biotech (Cambridge, Massachusetts). The author was project/corporate Vice- President, Chief Medical Officer Biopharmaceuticals, and Executive Scientific Advisor at Novo Nordisk A/S (Bagsvaerd, Denmark) 2005–2007. No one from any of these organizations had knowledge of, influenced, or participated in the writing of this letter.