congenital heart malformation inchildren
Conditions
Brief summary
The main purpose of the clinical trial is safety assessment regarding • Continuous adverse events (AEs) reporting up to 30 days postoperatively • Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until day 7 postoperatively (Area under the curve)
Detailed description
Description of hemodynamics (incl. vitals signs, blood gas parameters, catecholamine support, milrinone support), Description of echo, Description of cardiac injury (incl. creatinine kinase, troponin), Hospital/ ICU stay (readmissions, duration)/ Death, Description of surgery (incl. number of intraoperative administrations of cardioplegia), Description of 12-Lead-ECG, Description of cardiac arrhythmias (incl. need for pacemaker)
Interventions
Sponsors
Dr. Franz Koehler Chemie GmbH
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main purpose of the clinical trial is safety assessment regarding • Continuous adverse events (AEs) reporting up to 30 days postoperatively • Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until day 7 postoperatively (Area under the curve) | — |
Secondary
| Measure | Time frame |
|---|---|
| Description of hemodynamics (incl. vitals signs, blood gas parameters, catecholamine support, milrinone support), Description of echo, Description of cardiac injury (incl. creatinine kinase, troponin), Hospital/ ICU stay (readmissions, duration)/ Death, Description of surgery (incl. number of intraoperative administrations of cardioplegia), Description of 12-Lead-ECG, Description of cardiac arrhythmias (incl. need for pacemaker) | — |
Countries
Germany
Outcome results
None listed