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Abstract
Objective
Intraoperative arterial hypotension (IOH) is associated with poor patient outcome. This study aims to compare the hemodynamic effects of Cafedrine/Theodrenaline (C/T) and Noradrenaline (NA) for the treatment of hypotension in patients who develop IOH after anesthesia induction.
Research design and methods
This is a national, randomized, parallel-group, multicenter, and open-label study. Adult patients (≥50 years, ASA-classification III–IV) who undergo elective surgery will be included. When IOH (MAP <70 mmHg) develops, C/T or NA will be given as a bolus injection (“bolus phase”, 0–20 min after initial application) and subsequently as continuous infusion (“infusion phase”, 21–40 min after initial application) to achieve MAP = 90 mmHg. Hemodynamic data are captured in real time by advanced hemodynamic monitoring.
Results
Primary endpoints, i.e. the treatment-related difference in average mean arterial pressure (MAP) during the “infusion phase” and the treatment-related difference in average cardiac index during the “bolus phase” are assessed (fixed-sequence method). Non-inferiority of C/T compared to NA in achieving 90 mmHg (MAP) when applied as continuous infusion is hypothesized. In addition, superiority of C/T over NA, applied as bolus injection, in increasing cardiac index is postulated. It is estimated that 172 patients are required to establish statistical significance with a power of 90%. After adjusting for ineligibility and dropout rate, 220 patients will be screened.
Conclusion
This clinical trial will yield evidence for marketing authorization of C/T applied as continuous infusion. Additionally, the effects of C/T compared to NA on cardiac index will be assessed. First results of the “HERO”-study are expected in 2024. DRKS identifier: DRKS00028589. EudraCT identifier: 2021-001954-76.
Transparency
Declaration of financial/other relationships
The authors received no financial support for the authorship and/or publication of this article. L. Eberhart reports honoraria from Baxter Deutschland GmbH, Fresenius Kabi Deutschland GmbH, Grünenthal GmbH, Sintetica GmbH, and ratiopharm GmbH. B. Vojnar has received honoraria from ratiopharm GmbH. G. Geldner has received honoraria from ratiopharm GmbH. S. Huljic-Lankinen is an employee of ratiopharm GmbH. M. Murst is an employee of Teva GmbH. S. Weber is an employee of ACOMED statistik. T. Keller, ACOMED statistik, receives payments from the sponsor for statistical services (design and analysis) as part of this this study. T. Koch received honoraria for consulting from ratiopharm GmbH. P. Kranke has received honoraria for consulting from ratiopharm GmbH, Acacia Ltd, Amicus Clinical Development Ltd, BBraun, and Sintetica. He has received honoraria for lecturing from Fresenius Kabi Deutschland GmbH, Grünenthal GmbH, Baxter Deutschland GmbH, CSL Behring, Medtronic GmbH, Vifor Pharma, Pharmacosmos, and Sintetica. A. Weyland has received honoraria from ratiopharm GmbH. S. Kreuer is a shareholder of Saarmetrics GmbH, Saarbrücken, Germany. C. Gaik has received no payments. D. Chappell has received honoraria from ratiopharm GmbH, BBraun, Fresenius Kabi, Edwards Lifesciences, and Sintetica. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
The HERO study is funded by ratiopharm GmbH, Ulm, Germany. Editorial assistance for manuscript preparation was provided by CRO Dr. med. Kottmann GmbH & Co. KG, Hamm, Germany, with financial support from ratiopharm GmbH, Ulm, Germany.