Hydroxyethyl starch HES 130/0.4 in paediatric surgery: results of an explorative, controlled, multicentre safety study

Background

Human albumin (HA) has been the gold standard for plasma volume replacement in paediatric anaesthesia in the past while clinical experiences with artificial colloids such as hydroxyethyl starch (HES) are limited.

Patients and methods

After local EC approval and parents' signed consent, 2 × 41 patients (aged < 24 months) scheduled for major abdominal, cranial, thoracic, or urologic surgery were randomised to receive either 6% HES 130/0.4 (Voluven^®) or 5% HA for intra-operative volume replacement. Study parameters were haemodynamics, coagulation, laboratory parameters, and adverse events from induction of anaesthesia until day 3 postoperative. The treatment groups were compared descriptively by ANOVA or ANCOVA. Subgroup analyses were performed for age and dose of colloid. Predefined covariates were surgical procedure and duration, body weight, baseline value, and centre.

Results

Treatment groups were well balanced with respect to demographics, age groups, and surgical procedures. The mean dose of colloid infused (HES vs HA) until 6 hours postoperative was 16 ml/kg versus 17 ml/kg. No major differences were observed for infused crystalloids (67 ml/kg [HES] versus 65 ml/kg [HA]), changes of haemodynamics (blood pressure, heart rate) and also of laboratory parameters. In both groups, platelets and Quick decreased and aPTT increased postoperative; however, they were not clinically relevant. Adverse events were reported in 80% (HES) and 78% (HA) of patients, respectively. None of the adverse events were considered as probably drug related to HES or HA.

Conclusion

For the first time the novel HES 130/0.4 was clinically evaluated in newborns and infants. We conclude that HES 130/0.4 was well tolerated and as safe as human albumin in paediatric surgery.