Voluven® in Paediatric Patients

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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4021
    • AKh Allgemeines Krankenhaus der Stadt Linz GmbH
• Belgium
  • Brussels, Belgium, 1020
    • HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.; Other Names: Voluven®
Active Comparator: 2; Control drug: Human serum albumin (HSA 50g/L)	Drug: Human serum albumin (HSA 50g/L); Human serum albumin (HSA 50g/L)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Volume of Colloid Solution Required Intraoperatively	Total volume of study drug plus rescue colloid, if applicable	Day 1 (intraoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Fluid Input	Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning	2 days
Fluid Output	Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning	2 days
Fluid Balance	Balance of total fluid input and total fluid output	2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated Perioperative Red Blood Cell (RBC) Loss	Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit [baseline] - hematocrit [2nd postop morning]) + transfused RBC volume2; Predicted blood volume (mL) = 80 × body weight (kg); Transfused RBC volume = 0.7 × infused packed RBC	2 days
Length of Stay on the Intensive Care Unit (ICU)	Length of stay (number of days) on the intensive care unit (ICU).	From admission to ICU until discharge from ICU
Mortality	Mortality was reported for the time period from screening until the end of follow-up.	From screening to end of follow-up
Acute Renal Failure (ARF)	Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.	From baseline until 2nd postop morning.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 27, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (Estimate): March 12, 2009

Study Record Updates

• Last Update Posted (Estimate): November 2, 2011
• Last Update Submitted That Met QC Criteria: November 1, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: HE06-001-C P4