Voluven® in Paediatric Patients

• Mean Arterial Pressure (MAP) [ Time Frame: Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU) ] [ Designated as safety issue: No ]
  Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
• Fluid Input [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning
• Fluid Output [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning
• Fluid Balance [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  Balance of total fluid input and total fluid output

This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many settings. This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement therapy during elective open-heart surgery in paediatric patients. The hypothesis of this study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy and provide comparable safety during elective open-heart surgery in paediatric patients 2 to 12 years of age.

• Cardiac Surgery
• Cardiopulmonary Bypass

• Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)
  Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.
  Other Name: Voluven®
• Drug: Human serum albumin (HSA 50g/L)
  Human serum albumin (HSA 50g/L)

• Experimental: 1
  Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)
  Intervention: Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)
• Active Comparator: 2
  Control drug: Human serum albumin (HSA 50g/L)
  Intervention: Drug: Human serum albumin (HSA 50g/L)

Inclusion Criteria:

• Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC;
• Signed parental written informed consent and patient assent where achievable

Exclusion Criteria:

• Known contraindication against scheduled concomitant medication;
• Total ECC volume < 400 mL;
• ASA > III