Volume replacement therapy during elective open-heart surgery in paediatric patients MedDRA version: 9.1 Level: LLT Classification code 10048935 Term: Open heart surgery
Conditions
Interventions
Trade Name: Voluven® (HES 130/0,4) 6 % - Infusionslösung
Product Name: Voluven® (HES 130/0,4) 6 % - Infusionslösung
Pharmaceutical Form: Solution for injection
Trade Name: Human Albumin Baxter 50g/l
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC; 2. Signed parental written informed consent and patient assent where achievable Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to hydroxyethyl starch (such as rash), including its ingredients (inclusive corn) and related drugs; 2. Known or suspected allergy to human albumin preparations, including its ingredients and related drugs; 3. Known contraindication against scheduled concomitant medication; 4. Total ECC volume III; 6. Patients with abnormal haemostasis (fibrinogen < 100mg/dl, or INR above 1.5, or platelet count < 100 x109/L, or aPTT: 1.5 times above upper limit of normal); 7. Renal disease with oliguria or anuria not related to hypovolemia; 8. Fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure; 9. Patients receiving dialysis treatment; 10. Intracranial bleeding; 11. Severe hypernatremia or severe hyperchloremia; 12. Risk of non-compliance with study protocol; 13. Participation in a clinical drug trial within the last two months or concomitantly to this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate equivalence of 6 % HES 130/0.4 and 5% HSA with regard to the total volume of colloid solution (HES/HSA plus rescue colloid, if applicable) in mL/kg body weight required for intraoperative volume replacement including priming of the ECC;Secondary Objective: Secondary objectives are to compare haemodynamics, fluid input/output, the use of vasoactive and inotropic drugs, and safety parameters such as blood gas analyses, laboratory parameters, haemostasis, urinary biomarkers of acute kidney injury, blood loss and transfusion, patient outcome, and adverse events;Primary end point(s): The aim of the study is to prove equivalence, whereby the investigational drug is considered equivalent to the control drug, if the ratio of means investigational / control (plus any rescue colloid) is in the range 0.55 - 1.82. | — |
Countries
Austria, Belgium
Outcome results
None listed