Voluven® in Paediatric Patients

Fresenius Kabi61 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Surgery Cardiopulmonary Bypass

Interventions

HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)DRUG

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)DRUG

Human serum albumin (HSA 50g/L)

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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 (2)

AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, Austria

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

Outcomes

Primary Outcomes

Total Volume of Colloid Solution Required Intraoperatively

Total volume of study drug plus rescue colloid, if applicable

Time frame: Day 1 (intraoperatively)

Secondary Outcomes

Mean Arterial Pressure (MAP)

Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)

Time frame: 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

Time frame: 2 days

Fluid Output

Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning

Time frame: 2 days

Fluid Balance

Balance of total fluid input and total fluid output

Time frame: 2 days

Data from ClinicalTrials.gov

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