Voluven® in Paediatric Patients

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

Detailed Description
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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.

Official Title
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Efficacy and Safety of 6 % Hydroxyethyl Starch 130/0.4 (Voluven®) vs. 5% HSA in Volume Replacement Therapy During Elective Open-heart Surgery in Paediatric Patients

Conditions
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Cardiac Surgery, Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)
* Drug: Human serum albumin (HSA 50g/L)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion) | Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)<br>* 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.<br>* Other names: Voluven®;|
| Active Comparator: 2<br>Control drug: Human serum albumin (HSA 50g/L) | Drug: Human serum albumin (HSA 50g/L)<br>* Human serum albumin (HSA 50g/L)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Volume of Colloid Solution Required Intraoperatively | Total volume of study drug plus rescue colloid, if applicable | Day 1 (intraoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Pressure (MAP) | Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU) | Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU) | 
| Fluid Input | Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning | 2 days | 
| Fluid Output | Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning | 2 days | 
| Fluid Balance | Balance of total fluid input and total fluid output | 2 days |