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  • Meeting abstract
  • Open Access

Custodiol - N versus Custodiol: a prospective randomized double blind multicenter phase III Trial

  • 1,
  • 1,
  • 1,
  • 1,
  • 1,
  • 2,
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Journal of Cardiothoracic Surgery201510 (Suppl 1) :A73

https://doi.org/10.1186/1749-8090-10-S1-A73

  • Published:

Keywords

  • Catecholamine
  • Creatine
  • Creatine Kinase
  • Cardiac Index
  • Iron Chelator

Background/Introduction

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.

Aims/Objectives

In the present first-in-human study, Custodiol-N was compared with Custodiol in patients undergoing elective coronary bypass surgery.

Method

The study was designed as prospective randomized double blind non-inferiority trial. Primary end-point was area under the curve (AUC) of creatine kinase MB (CKMB) within the first 24 hours after surgery. Secondary endpoints included, peak CKMB and troponin-T and AUC of troponin-T release, cardiac index, cumulative catecholamine dose, ICU-stay and mortality. All values are given as mean ± SD, p < 0.05 was considered as 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. Patient characteristics, medical history, operation and cross-clamp times did not differ between the groups. CKMB AUC (878 ± 549 vs. 778 ± 439 h*U/l, non-inferiority p < 0.001) and Troponin-T AUC (12990 ± 8347 vs. 13498 ± 6513 h*pg/ml, non-inferiority p < 0.001) was similar in both groups. Although the trial was designed for non-inferiority, peak CKMB (52 ± 40 vs. 41 ± 30 U/l, superiority p < 0.002) was significantly lower in the Custodiol-N group. Cardiac index, catecholamines ICU-stay and mortality (1 death in the control group) was similar in both groups.

Discussion/Conclusion

This study shows that Custodiol-N is safe and provides similar cardiac protection as the established HTK-Custodiol solution. The significantly reduced peak CKMB levels in the Custodiol-N group may implicate a beneficial effect on ischemia/reperfusion injury in the setting of coronary bypass surgery.

Authors’ Affiliations

(1)
University of Heidelberg, Heidelberg, 69120, Germany
(2)
University of Hamburg, Hamburg, 20251, Germany
(3)
Heart Center Rotenburg, Rotenburg, 36199, Germany
(4)
University of Jena, Jena, 07747, Germany

Copyright

© Szabó et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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