Application of hypertonic hyperoncotic solutions for improvement of cardiac output after open heart surgery in children - monocentric, randomised, placebo controlled, double-blind clinical trial (phase IV) - HyperHAES-PÄD-CARDIO-02

• Conditions: Children after open-heart surgery for congenital cardiac disease; MedDRA version: 9.1Level: LLTClassification code 10019273Term: Heart disease congenital

• Registration Number: EUCTR2007-000390-31-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Written informed consent of the legal guardian and consent of the patient, if applicable
•Age: 1 month to 5 years
•Patients with up to now untreated cyanotic or acyanotic organic heart defects, after open-heart surgery with cardio-pulmonal-bypass
•Body weight: > 3,5 kg up to < 50 kg

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

•Age > 5 years
•Body weight < 3,5 kg or >50 kg
•Known hypersensitivity against hydroxyethyl starch in the patient's history
•Evidence in the patient's history of hemorrhagic diathesis
•Pre-surgical manifest heart insufficiency (NYHA-classification: degree IV)
•Thrombopenia (Thr <50000/mm3) at study inclusion
•Restricted renal function
(creatinin-clearance acc. to Schwartz < 30 ml/min/1,73 m2)
•Pre-surgical Na > 150 mmol/l
•Pre-surgical hyperchloremia
•Calculated serum osmolarity:> 350 mosm/l
•Acute life threatening hypovolemic shock
•Dehydration
•Hyperhydration
•Oliguria/Anuria
•Known disturbance of haemostasis
•Contraindications in the product information (SmPC) of HyperHAES® or Isotonische Kochsalzlösung Fresenius® do apply
•participation in another clinical trial with an investigational medicinal product.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified