Custodiol-N versus Custodiol: a prospective randomized double-blind multicentre phase III trial in patients undergoing elective coronary bypass surgery
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Media type:
E-Article
Title:
Custodiol-N versus Custodiol: a prospective randomized double-blind multicentre phase III trial in patients undergoing elective coronary bypass surgery
Description:
<jats:title>Abstract</jats:title>
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<jats:title>OBJECTIVES</jats:title>
<jats:p>HTK-Solution (Custodiol) is a well-established cardioplegic and organ preservation solution. We currently developed a novel HTK-based solution, Custodiol-N, which includes iron chelators to reduce oxidative injury, as well as l-arginine, to improve endothelial function. In this first-in-human study, Custodiol-N was compared to Custodiol in patients undergoing elective coronary artery bypass surgery. The aim of this comparison was to evaluate the safety and ability of Custodiol-N to protect cardiac tissue.</jats:p>
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<jats:title>METHODS</jats:title>
<jats:p>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 &lt; 0.05 was considered statistically significant.</jats:p>
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<jats:title>RESULTS</jats:title>
<jats:p>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 &lt; 0.001, Custodiol vs Custodiol-N) and troponin-T AUC (12990±8347 vs 13498±6513 h pg/ml, noninferiority P &lt; 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 &lt; 0.03, Custodiol vs Custodiol-N) was significantly lower in the Custodiol-N group.</jats:p>
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<jats:title>CONCLUSIONS</jats:title>
<jats:p>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.</jats:p>
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