Schaller, Stefan J.
Kiselev, Jörn
Loidl, Verena
Quentin, Wilm
Schmidt, Katrin
Mörgeli, Rudolf
Rombey, Tanja
Busse, Reinhard
Mansmann, Ulrich
Spies, Claudia http://orcid.org/0000-0002-1062-0495
,
Spies, Claudia
Marschall, Ursula
Eckardt-Felmberg, Rahel
Landgraf, Irmgard
Schwantes, Ulrich
Busse, Reinhard
Mansmann, Ulrich
,
Borchers, Friedrich
Mörgeli, Rudolf
Schönenberger, Eva
Klassen, Philipp
Kleikamp, Bernadette
Brandhorst, Philipp
Spiegel, Anna-Lena H.
Papenfuß, Bernhard
Dowideit, Jens
Oefele, Caroline
Gebhardt, Volker
Zappel, Kristina
Gövercin, Mehmet
König, Thomas
Chesi, Claudio
Reißhauer, Anett
Rosada, Adrian
Müller-Werdan, Ursula
Heymann, Anja
Hanke, Marion
Leymann, Jens
Saller, Thomas
Bischof, Ann-Cathrin
Reisner, Angelika
Albrecht, Wolf Leopold
Wojciechowski, Julia
Schuldt, Martina
Baum, Michael
Brnabic, Dijana
von Pickardt, Björn
Deutschmann, Agnieszka
Scholz, Carsten
May, Lars
Eckardt-Felmberg, Rahel
Wenghöfer, Isabell
Blobner, Manfred
Sattari, Sima
Dummert, Michael
Nau, Carla
Otto, Mareike
Voß-Lümers, Ute
Lang, Danny
Wiggert, Daniel
Funding for this research was provided by:
Gemeinsame Bundesausschuss (01NVF18024)
Charité - Universitätsmedizin Berlin
Article History
Received: 11 April 2022
Accepted: 12 May 2022
First Online: 6 June 2022
Change Date: 14 February 2023
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s13063-023-07106-5
Declarations
:
: The study has been approved by the ethical committee of the Charité – Universitätsmedizin Berlin as the primary study center (approval number EA1/225/19, see Additional file ). Any participation study center will either join the ethical approval of the Charité or, if needed, will have the study approved by the respective responsible ethical committee before starting to include patients. The study is registered at ClinicalTrials.gov with the trial registry number NCT04418271 and has the Universal Trial Number (UTN) U1111-1253-4820. The current study protocol is version 1.1 (13.06.2020). The trial will be conducted in agreement with the principles of the Declaration of Helsinki. 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. The Department of Anesthesiology and Operative Intensive Care Medicine of the Charité – Universitätsmedizin Berlin coordinates the study. The original study protocol (in German) and the statistical analysis plan including amendments are publicly available at the project’s website [].Protocol amendments:Any changes to the protocol that affect or could affect the study design or procedures, the objectives and hypotheses, or patient safety must be submitted as an amendment to the ethics committees of the study centers for consultation. The new version of the study protocol will be made available at the project’s website, including the rationale for any changes. The clinical trials entry will be adjusted if necessary.Minor changes, such as organizational adjustments, changes in written manuals for the pure reason of clarification of any processes, or changes in responsibilities that have no effects on the defined study goals and conduction, will be agreed upon by the management committee of PRAEP-GO. In such cases, the ethical committee of the leading study center will be notified of such changes.
: Not applicable.
: SJS received grants from Reactive Robotics GmbH (Munich, Germany); grants and non-financial support from STIMIT AG (Biel, Switzerland), Liberate Medical LLC (Crestwood USA), and ESICM (Geneva, Switzerland); grants, personal fees, and non-financial support from Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany); personal fees from Springer Verlag GmbH (Vienna, Austria) for educational purposes; and non-financial support from Technical University of Munich (Munich, Germany) and from national and international societies (and their congress organizers) in the field of anesthesiology and intensive care medicine, outside the submitted work. Dr. Schaller held stocks in small amounts from Rhön-Klinikum AG and holds stocks in small amounts from Alphabeth Inc., Bayer AG, and Siemens AG; these holdings have not affected any decisions regarding his research or this study.J Kiselev declares no competing interests.V Loidl declares no competing interests.W Quentin declares no competing interests.K Schmidt declares no competing interests.R Mörgeli declares no competing interests.T Rombey received honorary fees for commissioned research by the Statutory Health Insurance Medical Review Board.R Busse declares no competing interests.U Mannsmann declares no competing interests.C Spies reports grants from Gemeinsamer Bundesausschuss/Federal Joint Committee (G-BA) during the conduct of the study, grants from BMG/RKI, grants from Deutsche Forschungsgemeinschaft/German Research Society, grants from Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)/German Aerospace Center, grants from Einstein Stiftung Berlin/Einstein Foundation Berlin, grants from Inneruniversitäre Forschungsförderung/Inner University Grants, grants from Projektträger im DLR/Project Management Agency, grants from Stifterverband/Non-Profit Society Promoting Science and Education, grants from European Society of Anaesthesiology and Intensive Care, grants from Baxter Deutschland GmbH, grants from Cytosorbents Europe GmbH, grants from Edwards Lifesciences Germany GmbH, grants from Fresenius Medical Care, grants from Grünenthal GmbH, grants from Masimo Europe Ltd., grants from Pfizer Pharma PFE GmbH, personal fees from Georg Thieme Verlag, grants from Dr. F. Köhler Chemie GmbH, grants from Sintetica GmbH, grants from Stifterverband für die deutsche Wissenschaft Þ.V./PhilipsÐ grants from Stiftung Charité, grants from AGUETTANT Deutschland GmbH, grants from AbbVie Deutschland GmbH & Co. KG, grants from Amomed Pharma GmbH, grants from InTouch Health, grants from Copra System GmbH, grants from Correvio GmbH, grants from Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V., grants from Deutsche Gesellschaft für Anästhesiologie & Intensivmedizin (DGAI, grants from Stifterverband für die deutsche Wissenschaft e.V./Metronic, grants from Philips Electronics Nederland BV, grants from BMG/RKI, grants from BMBF, grants from Deutsche Forschungsgemeinschaft/German Research Society, and grants from Drägerwerk AG & Co. KGaA, outside the submitted work. In addition, Dr. Spies has a patent 10 2014 215 211.9 licensed, a patent 10 2018 114 364.8 licensed, a patent 10 2018 110 275.5 licensed, a patent 50 2015 010 534.8Ð licensed, a patent 50 2015 010 347.7 licensed, and a patent 10 2014 215 212.7 licensed.