Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.
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 cardiopulmonary bypass for coronary artery bypass surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (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
102
Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes
Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused
Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen
Essen, Germany
Abt. Herzchirugie, Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Jena, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
CK-MB area under the curve within 24 hours
Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp
Time frame: Up to 24 hours after the aortic clamp release
Catecholamine requirement
Catecholamine requirement on surgical ICU within 24 hours
Time frame: 24 hours (cumulative dose)
CK-MB peak
CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp
Time frame: Up to day 5
Mortality any time during post-op through Day 30
Mortality will be documented at any time during post-op through Day 30
Time frame: Up to Day 30
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