Voluven® in Paediatric Patients
Launched by FRESENIUS KABI · Mar 11, 2009
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
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 ...
Gender
ALL
Eligibility 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
About Fresenius Kabi
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technology, with a strong focus on the areas of intravenous (IV) therapies, infusion devices, and clinical nutrition. With a commitment to enhancing patient care, Fresenius Kabi conducts innovative clinical trials to develop high-quality pharmaceuticals and medical devices that address unmet medical needs. The company leverages its extensive expertise in drug formulation and delivery systems to advance therapeutic solutions across various clinical indications, ensuring safety and efficacy in diverse patient populations. Through its robust research and development initiatives, Fresenius Kabi aims to contribute significantly to the healthcare landscape and improve outcomes for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Linz, , Austria
Brussels, , Belgium
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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