Voluven® in Paediatric Patients

Fresenius Kabi

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Cardiopulmonary Bypass

Treatments: 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)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860405

HE06-001-C P4

Details and patient eligibility

About

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

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups

1

Experimental group

Description:

Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)

Treatment:

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

2

Active Comparator group

Description:

Control drug: Human serum albumin (HSA 50g/L)

Treatment:

Drug: Human serum albumin (HSA 50g/L)