Voluven® in Paediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00860405
First received: February 27, 2009
Last updated: November 1, 2011
Last verified: October 2011

February 27, 2009
November 1, 2011
March 2009
August 2010   (final data collection date for primary outcome measure)
Total Volume of Colloid Solution Required Intraoperatively [ Time Frame: Day 1 (intraoperatively) ] [ Designated as safety issue: No ]
Total volume of study drug plus rescue colloid, if applicable
Total volume of colloid solution [ Time Frame: Day 1(intraoperatively) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00860405 on ClinicalTrials.gov Archive Site
  • 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
Hemodynamics Fluid input/output Use of vasoactive and inotropic drugs Laboratory values [ Time Frame: Day 1 - Day 3 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Voluven® in Paediatric Patients
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
December 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium
 
NCT00860405
HE06-001-C P4
Not Provided
Fresenius Kabi
Fresenius Kabi
Not Provided
Principal Investigator: Philippe Van der Linden, Professor HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
Principal Investigator: Hans Gombotz, Professor AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Fresenius Kabi
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP