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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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

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 < 400 mL;
5. ASA > 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

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