Hypervolumetric hemodilution with HES 100/0.5 10% in patients with peripheral arterial occlusive disease (Fontaine, stage II): An open clinical and pharmacological phase IV study

The efficacy of three weekly interventions with hypervolumetric hemodilutio n of a new preparation of hydroxyethyl starch (HES 100/0.5, 10%, C2/C6 subs titution ratio of 6.5) on pain-free walking distance of patients with perip heral arterial occlusive disease (PAOD) stage IIb on the Fontaine classific ation was investigated. In addition quantitative data on the pharmacokineti c properties of this HES preparation, and it's impact on hemorheology, hemo stasis and homeostasis were shown. Ten patients were included according to a predefined protocol, and treated openly with 500 mi HES 100/0.5 10% on nine occasions over 18 days. Pain-free walking distance, the main outcome measure, showed a mean increas e of 82 m (+60%). Hematocrit decreased 4 percentage points on average (5.5 percentage points one hour after interventions). Plasma viscosity dropped 5 % on average with significant changes immediately after interventions only in patients whose baseline values had been equal to or above the 2 s refere nce area. Erythrocyte aggregation decreased by 16% in the course of treatme nt (8% immediately after interventions), systolic blood pressure by 13%, an d total protein by 7%. Complement showed a trend towards lower values (-20% ), and creatinine, pH and urine viscosity remained unchanged. Apart from co mplement changes, all reductions mirrored the dilution effects. As to pharmacokinetics, serum mean molecular weight distribution was very s imilar to that of the infusion. A minor adverse drug reaction (light, spont aneously disappearing pruritus) was observed in one case.