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Voluven� in Paediatric Patients

Information source: Fresenius Kabi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Surgery; Cardiopulmonary Bypass

Intervention: 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) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fresenius Kabi

Official(s) and/or principal investigator(s):
Philippe Van der Linden, Professor, Principal Investigator, Affiliation: HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
Hans Gombotz, Professor, Principal Investigator, Affiliation: AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Total Volume of Colloid Solution Required Intraoperatively

Secondary outcome:

Mean Arterial Pressure (MAP)

Fluid Input

Fluid Output

Fluid Balance

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

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

AKh Allgemeines Krankenhaus der Stadt Linz GmbH, Linz 4021, Austria

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola, Brussels 1020, Belgium

Additional Information

Starting date: March 2009
Last updated: November 1, 2011

Page last updated: August 23, 2015

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