Voluven® in Paediatric Patients

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860405
• Other study ID #: HE06-001-C P4
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2009
• Last updated: November 1, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

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

Locations

Country	Name	City	State
Austria	AKh Allgemeines Krankenhaus der Stadt Linz GmbH	Linz
Belgium	HUDERF - Hôpital Universitaire des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Countries where clinical trial is conducted

Austria,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Volume of Colloid Solution Required Intraoperatively	Total volume of study drug plus rescue colloid, if applicable	Day 1 (intraoperatively)	No
Secondary	Mean Arterial Pressure (MAP)	Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)	Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)	No
Secondary	Fluid Input	Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning	2 days	No
Secondary	Fluid Output	Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning	2 days	No
Secondary	Fluid Balance	Balance of total fluid input and total fluid output	2 days	No