Clinical trial NCT00860405: Voluven® in Paediatric Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 61
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total Volume of Colloid Solution Required Intraoperatively
timeFrame: Day 1 (intraoperatively)
Secondary outcomes:
measure: Mean Arterial Pressure (MAP)
timeFrame: Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
measure: Fluid Input
timeFrame: 2 days
measure: Fluid Output
timeFrame: 2 days
measure: Fluid Balance
timeFrame: 2 days
Other outcomes:
measure: Calculated Perioperative Red Blood Cell (RBC) Loss
timeFrame: 2 days
measure: Length of Stay on the Intensive Care Unit (ICU)
timeFrame: From admission to ICU until discharge from ICU
measure: Mortality
timeFrame: From screening to end of follow-up
measure: Acute Renal Failure (ARF)
timeFrame: From baseline until 2nd postop morning.
Locations:
city: Linz
country: Austria
facility: AKh Allgemeines Krankenhaus der Stadt Linz GmbH
city: Brussels
country: Belgium
facility: HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
Study officials:
affiliation: HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
name: Philippe Van der Linden, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AKh Allgemeines Krankenhaus der Stadt Linz GmbH
name: Hans Gombotz, Professor
role: PRINCIPAL_INVESTIGATOR
References: