Voluven® in Paediatric Patients

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2010

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Total Volume of Colloid Solution Required Intraoperatively
    • Time Frame: Day 1 (intraoperatively)
    • Total volume of study drug plus rescue colloid, if applicable

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fresenius Kabi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe Van der Linden, Professor, Principal Investigator, HUDERF – Hôpital Universitaire des Enfants Reine Fabiola
    • Hans Gombotz, Professor, Principal Investigator, AKh Allgemeines Krankenhaus der Stadt Linz GmbH

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