In several clinical studies it has been shown that hydroxyethyl starch (HES) may be as effective and safe but less expensive as albumin when used for perioperative plasma volume replacement in children. The new third-generation HES 130/0.42 solution was designed to reduce adverse drug reactions (ADR) and improve safety while maintaining efficacy. In this prospective multicentric observational postauthorization safety study, therefore, the perioperative application of HES 130/0.42 was examined in children with a focus on possible ADR.
In the first year approximately 300 pediatric patients aged up to 12 years with risk score ASA I–III undergoing perioperative application of HES 130/0.42 (Venofundin 6%; Braun, Germany) should be included. According to statistics, this number of patients is sufficient to show a 1% occurrence of ADR. After approval of a local ethic commission, patient data and those relating to the application of HES 130/0.42, the performed procedure, anaesthesia-related data and ADR were documented with focus on cardiovascular stability, hemodilution, acid–base balance, renal function, blood coagulation and hypersensitivity.
Three hundred and sixteen children (ASA I–III, age 3 (SD 3.4, range day of birth–12) years, body weight 13 (SD 10.5, range 1.1–60) kg) were studied in five centres in Germany, Austria and Italy until August 2007. Forty-five percent of the patients underwent abdominal, 12.4% urological, 11.4% thoracic, 7.6% orthopedic and 7% cardiac surgical procedures. The mean volume of infused HES 130/0.42 was 11 (SD 4.8, range per day 5–42) ml/kg. Cardiovascular stability was maintained in all cases. After HES infusion, values of hemoglobin (11.5 vs 10.25 g/dl), base excess (-2 vs -2.7 mmol/l), anion gap (12.9 vs 11.17 mmol/l) and strong ion difference (34.3 vs 31.4 mmol/l) decreased and chloride (105.7 vs 107.8 mmol/l) increased significantly (P < 0.05). No serious ADR (i.e. bleeding, renal insufficiency, hypersensitivity) were observed.
Moderate doses of HES 130/0.42 help to maintain cardiovascular stability and lead to only moderate changes in haemoglobin concentration and acid–base balance in children. The probability of serious ADR is lower than 1%. HES 130/0.42/6:1 for plasma volume replacement therefore seems to be safe and effective even in neonates and small infants.