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Article History

Received: 19 October 2019

Accepted: 26 July 2020

First Online: 18 August 2020

Ethics approval and consent to participate

: The study is approved by the ethics committee of the School of Medicine of the Technical University of Munich (approval number 359/16) and the competent national authority in Germany (Paul-Ehrlich Institut, Langen, Germany, approval number 2880/01). The study is registered in EudraCT (2016-001313-24) in ClinicalTrials (NCT03167645) and has the Universal Trial Number (UTN) U1111-1181-2625. The current study protocol is version 4.1 (08.08.2018). The trial will be conducted in agreement with the principles of the Declaration of Helsinki and the German Pharmaceuticals Act. All participants will be informed about the purpose of the trial, the risks, and the potential benefits. There is no anticipated harm and compensation for trial participation. Written informed consent will be obtained by the local study physician from each participant including the hospital’s policy of collection and storage of biological specimens. The Department of Anesthesiology and Intensive Care of the School of Medicine, Technical University of Munich, will coordinate the study. The original study protocol (in German) and the statistical analysis plan including amendments are publicly available at.

: The study report will be submitted for publication to a peer-reviewed medical journal. In addition, it will be made available via the department’s website. Furthermore, a study report will be submitted to the related authorities.

: SJS reports grants from MSD (Haar, Germany); non-financial support from Fresenius, Germany, from the Technical University of Munich, Germany, and from national (e.g., DGAI) and international (e.g., ESICM) medical societies or their congress organizers in the field of anesthesiology and intensive care; and personal fees and non-financial support from Bavarian Medical Association, all outside the submitted work; he holds stocks from Alphabet Inc., Rhoen-Klinikum, Bayer AG, and Siemens AG; these holdings have not affected any decisions regarding his research or this study. TS has received research funding grants from Bayer Pharm (Berlin, Germany) and is a lecturer for Bayer Pharm (Berlin, Germany), Bristol-Myers Squibb (Munich, Germany), Pfizer (Berlin, Germany), and Daiichi Sankyo (Munich, Germany). MB received research support from MSD (Haar, Germany) not related to this manuscript and received honoraria for giving lectures from GE Healthcare (Helsinki, Finland) and Grünenthal (Aachen, Germany). BJ received honoraria for giving lectures from Pulsion Medical Systems SE (Feldkirchen, Germany). The other authors declare that they have no competing interests.