Conditions: Cardiac Surgery Cardiopulmonary Bypass
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: no

Brief summary:
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.

Detailed description:

Arms:
arm 1: Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®) arm 2: Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)

Interventions: intervention 1: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution intervention 2: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Intervention descriptions: intervention 1: Peri-operative fluid replacement therapy (max 40ml/kg/day) intervention 2: Peri-operative fluid replacement therapy (max 40ml/kg/day)

Protocol document: