Voluven® in Paediatric Patients - Full Text View

Sponsored by:	Fresenius Kabi
Information provided by:	Fresenius Kabi
ClinicalTrials.gov Identifier:	NCT00860405

Purpose

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

Condition	Intervention	Phase
Cardiac Surgery Cardiopulmonary Bypass	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)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Surgery

Drug Information available for: Albumins, human Sodium chloride

U.S. FDA Resources

Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:

Total volume of colloid solution [ Time Frame: Day 1(intraoperatively) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hemodynamics Fluid input/output Use of vasoactive and inotropic drugs Laboratory values [ Time Frame: Day 1 - Day 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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) 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.
2: Active Comparator Control drug: Human serum albumin (HSA 50g/L	Drug: Human serum albumin (HSA 50g/L) Human serum albumin (HSA 50g/L)

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.

Eligibility

Ages Eligible for Study:	2 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860405

Contacts

Contact: Daniela Baus

+49-(0)6172 608 7324

daniela.baus@Fresenius-Kabi.com

Locations

Austria
AKh Allgemeines Krankenhaus der Stadt Linz GmbH	Recruiting
Linz, Austria, 4021
Contact: Hans Gombotz, Professor 0043-(0)732-7806-2158 hans.gombotz@akh.linz.at
Belgium
HUDERF - Hôpital Universitaire des Enfants Reine Fabiola	Recruiting
Brussels, Belgium, 1020
Contact: Philippe Van der Linden, Professor 0032-(0)2-477-2330 philippe.vanderlinden@chu-brugmann.be

Sponsors and Collaborators

Fresenius Kabi

Investigators

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

More Information

No publications provided

Responsible Party:	Fresenius Kabi Deutschland GmbH ( Daniela Baus , Clinical Project Manager )
Study ID Numbers:	HE06-001-C P4
Study First Received:	February 27, 2009
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00860405 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hetastarch

ClinicalTrials.gov processed this record on September 10, 2009