Abstract | OBJECTIVES: METHODS: The study was designed as a prospective randomized double-blind non-inferiority trial. Primary end point was area under the curve (AUC) of creatine kinase muscle-brain (CK-MB) within the first 24 h after surgery. Secondary end points included peak CK-MB and troponin-T and AUC of troponin-T release, cardiac index, cumulative catecholamine dose, intensive care unit stay and mortality. All values in the abstract are given as mean ± SD, P < 0.05 was considered statistically significant. RESULTS: Early termination of the trial was performed per protocol as the primary non-inferiority end-point was reached after inclusion of 101 patients. CK-MB AUC (878±549 vs 779±439 h U/l, non-inferiority P < 0.001, Custodiol vs Custodiol-N) and troponin-T AUC (12990±8347 vs 13498±6513 h pg/ml, noninferiority P < 0.001, Custodiol vs Custodiol-N) were similar in both groups. Although the trial was designed for non-inferiority, peak CK-MB (52±40 vs 42±28 U/l, superiority P < 0.03, Custodiol vs Custodiol-N) was significantly lower in the Custodiol-N group. CONCLUSIONS: This study shows that Custodiol-N is safe and provides similar cardiac protection as the established HTK- Custodiol solution. Significantly reduced peak CK-MB levels in the Custodiol-N group in the full analysis set may implicate a beneficial effect on ischaemia/ reperfusion injury in the setting of coronary bypass surgery.
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Authors | Gábor Szabó, Paige Brlecic, Sivakkanan Loganathan, Florian Wagner, Ardawan Rastan, Torsten Doenst, Matthias Karck, Gábor Veres |
Journal | European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery
(Eur J Cardiothorac Surg)
Vol. 62
Issue 5
(10 04 2022)
ISSN: 1873-734X [Electronic] Germany |
PMID | 35579350
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © The Author(s) 2022. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. |
Chemical References |
- Bretschneider cardioplegic solution
- Custodiol-N solution
- Organ Preservation Solutions
- Troponin T
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Topics |
- Humans
- Coronary Artery Bypass
(methods)
- Organ Preservation Solutions
- Prospective Studies
- Troponin T
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