Congenital Heart Malformations
Conditions
Brief summary
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)
Detailed description
Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
Interventions
DRUGheart will be treated with Custodiol-N
cardioplegia solution will be administered with perfusion
DRUGheart will be treated with Custodiol
cardioplegia solution will be administered with perfusion
Sponsors
Dr. F. Köhler Chemie GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
Eligibility
Sex/Gender
ALL
Age
24 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age from birth to less than 18 years of age * congenital heart surgery with cardiopulmonary bypass and cardioplegia * written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study) * Ability of the legal guardians to understand character and individual consequences of the clinical trial
Exclusion criteria
* Patients who have participated within 30 days or are still participating in any other interventional study * History of severe organic (e.g. liver or kidney) disease other than concerning the heart * History of psychiatric disease * Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety assessment | AEs up to 30 days postoperatively | Continuous adverse events (AEs) reporting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of hemodynamics | day 7 postoperatively | Vital signs (blood pressure (mmHg)) |
| Description of echo | Baseline, after skin closure and day 7 postoperatively | Systemic-ventricular function (good, moderately impaired, severely impaired) |
| Description of cardiac injury | at baseline until postoperative day 2 and postoperative day 7 or discharge | Creatine kinase (CK (U/l)) |
| Description of hospitals stay/ death | 30 days postoperatively | Death (date) |
| Description of surgery | during surgery | Aortic cross clamping time (min) |
| Description of 12-Lead-ECG | baseline and day 1 postoperatively (Intensive Care Unit) | Shift in 12-Lead-ECG (ECG QT Interval) |
| Description of cardiac arrhythmias | until day 7 postoperatively | Current heart rhythm (Sinus rhythm, atrioventricular block (AV-Block °I), AV-Block °II, AV-Block °III, Ectopic atrial rhythm with intact AV conduction, other tachycardiac arrhythmia) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORPhilippe Grieshaber, PD Dr.
Sektion Kinderherzchirurgie, Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Münster, Germany
PRINCIPAL_INVESTIGATORChristine-Elena Kamla, Dr.
Deutsches Herzzentrum München, TUM Universitätsklinikum, Germany
PRINCIPAL_INVESTIGATORMohamed Salem, Dr.
Kinderherzzentrum, Universitätsklinikum Gießen und Marburg GmbH, Germany
Outcome results
None listed