The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
530
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Klinik für Herzchirurgie, Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg
Rotenburg an der Fulda, Hesse, Germany
Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig
Leipzig, Saxony, Germany
Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena
Jena, Thuringia, Germany
Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen
Aachen, Germany
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
Hamburg, Germany
peak value for CK-MB
Time frame: measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp
Catecholamine requirement on SICU
Time frame: within 24 hours (cumulative dose)
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