Assessment of the safety and tolerance of 6% hydroxyethyl starch (200/0.5) solution: a randomized, controlled epidemiology study.

UNLABELLED: None of the natural and synthetic colloids currently available is free from the risk of side effects. This study was performed to contribute to the epidemiology of adverse reactions of the widely used 200/0.5 hydroxyethyl starch 6% solution (HES). Study end points were anaphylactoid reactions during preanesthesia infusion and perioperative course, and pruritus 5 days postoperatively (clinical examination and inquiry) and 8 wk after application (mailed patient questionnaire). We consecutively randomized 750 patients undergoing minor elective surgery into two parallel groups treated with HES (from two different manufacturers) and one control group treated with lactated Ringer's solution. The study population was well matched among the groups and consisted of patients of both sexes, aged 18-95 yr, ASA physical status I-III. No drug-related anaphylactoid reactions were detected during either of the observation intervals. There was no episode of pruritus after the fifth postoperative day. Incidence of pruritus after 8 wk was quite frequent but not significantly different (chi2 test, P = 0.77): 9.1% and 12.0% in the two HES groups and 11.5% in the lactated Ringer's solution control group. Except for pruritus, we conclude that HES was associated with no more complications than lactated Ringer's solution. IMPLICATIONS: Anaphylactoid reactions and pruritus (itching) after the administration of a 6% hydroxyethyl starch (200/0.5) versus lactated Ringer's solution were assessed in a prospective, randomized, controlled study. There were no differences, although there was a more than 10% incidence of pruritus in both groups.

Large-dose administration of 6% hydroxyethyl starch 200/0.5 total hip arthroplasty: plasma homeostasis, hemostasis, and renal function compared to use of 5% human albumin.

Within a daily dose of 20 mL/kg, medium-molecular hydroxyethyl starch (HES) is a safe and effective colloid for intravascular blood volume replacement. The effect of large doses on coagulation and renal function is unknown. We prospectively studied 41 patients undergoing total hip arthroplasty during the perioperative period. Inevitable blood loss was replaced with HES (HES group) or albumin (ALB group) in combination with packed red blood cells (PRBC), fresh frozen plasma (FFP), and platelets. Hemodynamic, oncotic, coagulation, and renal functions were compared initially, at the end of surgery, during the postoperative period (1, 3, and 6 h), and also with respect to the volume of colloid solution administered (1500, 2000, and 3000 mL). Total intake and output balances, as well as the costs of blood replacement therapy, were registered at the end of the study. We found differences in oncotic variables even at 6 h after surgery (total serum proteins [TSP]:HES 36.4 +/- 7.9 g/L versus ALB 55.6 +/- 6.1 g/L, P < 0.01; serum albumin:HES 25.5 +/- 5.3 g/L versus ALB 42.0 +/- 5.6 g/L, P < 0.01). Colloid osmotic pressure (COP) and hemodynamic, coagulation, and renal functions were comparable, as was total blood loss (HES 4247 +/- 2090 mL versus ALB 4051 +/- 2830 mL). Total requirements for colloid solutions (HES 35.9 +/- 7.4 mL/kg versus ALB 33.9 +/- 10.5 mL/kg), PRBC, FFP, or platelets were comparable, whereas total cost of blood replacement therapy was 33% less in the HES group. With respect to efficacy and side effects on coagulation and renal function, medium molecular HES is an appropriate and economic alternative to albumin at daily doses of up to at least 36 mL/kg.