Comparison of HES 130/0.42 and HES 200/0.5 for hemodynamic stabilisation in major urological surgery

Purpose: Different hydroxyethyl starches (HES) may lead to different volume effects. We compared a new HES130/0.42 with an established HES200/0.5 with respect to perioperative volume requirements, hemodynamic effects, safety and tolerability. Methods: After approval of the local ethics committee we investigated in a prospective, randomized double-blinded clinical trial 100 adult patients scheduled for elective major urological surgery. The study fluids were administered according to patients ́ individual need from induction of anesthesia until 12:00 midnight on the day of surgery. Infusion trigger were mean arterial pressure, central venous pressure, heart rate, or other clinical reasons. The required volume of study medication served as primary endpoint. Secondary endpoints were safety and tolerability. Equivalence was tested using the confidence interval inclusion method. A p < 0.05 indicates a high probability of equivalence. Hemodynamic and laboratory data were compared with the t-test, Mann-Whitney U-test or chi2-test as appropriate. In this case a probability value of less than 0.05 was considered as statistically significant. Results: Groups did not differ at baseline. Intraoperatively and during ICU stay equivalent amounts of HES were administered [mean ± SD] (HES 130/0.42: 1150 ± 574mL vs. HES 200/0.5: 1070 ± 572mL, p = 0.0002 (OP); HES 130/0.42: 1390 ± 955 mL vs. HES 200/0.5: 1245 ± 715 mL, p = 0.0196 (ICU)). Statistical equivalence over the whole observation period could not be achieved (HES 130/0.42: 2540 ± 1232 mL, HES 200/0.5: 2290 ± 1040mL, p = 0.1379). There was no difference in total fluid requirements, hemodynamics, routine chemistry, and blood coagulation parameters. Intraoperatively red blood cells were administered more frequently in group HES 200/0.5 (HES 130/0.42: 4/50 patients; HES200/0.5: 11/50 patients; p = 0.0499). Over the entire observation period no serious adverse events occurred. Conclusions: HES 130/0.42 can be used as safely and efficiently for perioperative plasma volume expansion to maintain hemodynamic stability during major urological surgery as a standard HES 200/0.5 formulation.