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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
cardioplegia solution will be administered with perfusion
cardioplegia solution will be administered with perfusion
Universitätsklinikum Gießen und Marburg GmbH, Abteilung für Kinderherzchirurgie und angeborene Herzfehler
Giessen, Germany
Deutsches Herzzentrum München, TUM Universitätsklinikum, Klinik für Chirurgie angeborener Herzfehler und Kinderherzchirurgie
München, Germany
Universitätsklinikum Münster, Klinik für Herz- und Thoraxchirurgie,Sektion Kinderherzchirurgie
Münster, Germany
safety assessment
Continuous adverse events (AEs) reporting
Time frame: AEs up to 30 days postoperatively
safety assessment
Myocardial protection in surviving patients assessed by quantification of perioperative CK-MB levels (U/l)
Time frame: CK-MB (Creatinkinase-MB) levels at baseline until postoperative day 2 and postoperative day 7 or discharge
Description of hemodynamics
Vital signs (blood pressure (mmHg))
Time frame: day 7 postoperatively
Description of hemodynamics
Vital signs (heart rate (bpm))
Time frame: day 7 postoperatively
Description of hemodynamics
Vital signs (body temperature (°C))
Time frame: day 7 postoperatively
Description of hemodynamics
Vasopressor/ Catecholamine/ Vasodilator (incl. Milrinone)/ Levosimendan intake (yes/no by timepoint and amount (μg/kg/min))
Time frame: day 7 postoperatively
Description of hemodynamics
Nitric oxide ventilation (yes/no by timepoint)
Time frame: day 7 postoperatively
Description of hemodynamics
Extracorporeal membrane oxygenation (ECMO) support (yes/no by timepoint)
Time frame: day 7 postoperatively
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Description of hemodynamics
Need for placement of a permanent Medical Circulatory Support (MCS) (left ventricular assist device (LVAD), right ventricular assist device (RVAD), biventricular assist support (BiVAD)), (yes/no by timepoint)
Time frame: 30 days postoperatively
Description of hemodynamics
Need for heart transplant (yes/no by timepoint)
Time frame: 30 days postoperatively
Description of echo
Systemic-ventricular function (good, moderately impaired, severely impaired)
Time frame: Baseline, after skin closure and day 7 postoperatively
Description of cardiac injury
Creatine kinase (CK (U/l))
Time frame: at baseline until postoperative day 2 and postoperative day 7 or discharge
Description of cardiac injury
Troponin T (ng/ml)
Time frame: at baseline until postoperative day 2 and postoperative day 7 or discharge
Description of hospitals stay/ death
Death (date)
Time frame: 30 days postoperatively
Description of hospitals stay/ death
readmission (to hospital or intensive care), (yes/no and number)
Time frame: 30 days postoperatively
Description of hospitals stay/ death
Length of ICU stay (start and end date)
Time frame: 30 days postoperatively
Description of hospitals stay/ death
Length of hospital stay (start and end date)
Time frame: 30 days postoperatively
Description of surgery
Aortic cross clamping time (min)
Time frame: during surgery
Description of surgery
Incision-to-closure-time (min)
Time frame: during surgery
Description of surgery
Reperfusion time (min)
Time frame: during surgery
Description of surgery
Number of intraoperative administrations of cardioplegia
Time frame: during surgery
Description of surgery
Total administration duration (min)
Time frame: during surgery
Description of surgery
Total administration amount (ml)
Time frame: during surgery
Description of 12-Lead-ECG
Shift in 12-Lead-ECG (ECG QT Interval)
Time frame: baseline and day 1 postoperatively (Intensive Care Unit)
Description of cardiac arrhythmias
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)
Time frame: until day 7 postoperatively
Description of cardiac arrhythmias
Tachyarrhythmic event since last visit (JET/atrial fibrillation/atrial flutter/ ventricular arrhythmia)
Time frame: until day 7 postoperatively
Description of cardiac arrhythmias
Need for antiarrhythmic therapy other than beta blockers after end of aortic cross-clamping since last visit (e.g. Adenosine, Amiodarone, Flecainid), (yes/no)
Time frame: until day 7 postoperatively
Description of cardiac arrhythmias
Current cardiac pacing (none/atrial/ventricular/sequential)
Time frame: 30 days postoperatively