Voluven® in Paediatric Patients

Phase 4

Completed

• Conditions: Cardiac Surgery; Cardiopulmonary Bypass
• Interventions: Drug: Human serum albumin (HSA 50g/L); Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)

• Registration Number: NCT00860405
• Lead Sponsor: Fresenius Kabi

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-02-27
• Study Start: 2009-03
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2010-08
• Study Completion: 2010-12
• Results First Submitted: 2011-08-12
• Results First Submitted QC: 2011-08-12
• Results First Posted: 2011-09-19
• Status Verified: 2011-10
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Human serum albumin (HSA 50g/L)	Control drug: Human serum albumin (HSA 50g/L)
1	HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)	Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)

Primary Outcome Measures

Name	Time	Method
Total Volume of Colloid Solution Required Intraoperatively	Day 1 (intraoperatively)	Total volume of study drug plus rescue colloid, if applicable

Secondary Outcome Measures

Name	Time	Method
Mean Arterial Pressure (MAP)	Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)	Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
Fluid Input	2 days	Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning
Fluid Output	2 days	Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning
Fluid Balance	2 days	Balance of total fluid input and total fluid output

Trial Locations

Locations (2)

AKh Allgemeines Krankenhaus der Stadt Linz GmbH; 🇦🇹 Linz, Austria

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium