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Authors
Varkila, Meri R. J. https://orcid.org/0000-0002-2831-0292
Lancia, Giacomo
van Smeden, Maarten
Bonten, Marc J. M.
Spitoni, Cristian
Cremer, Olaf L.
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Funding
Funding for this research was provided by:
European Society of Intensive Care Medicine
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Article History
Received: 30 April 2024
Accepted: 14 May 2025
First Online: 21 July 2025
Declarations
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: This study was performed using data from the Molecular Diagnosis and Risk Stratification of Sepsis (MARS) project (ClinicalTrials.gov identifier NCT01905033, date January 2011), a prospective ICU cohort study, for which the institutional review boards, Medical Research Ethics Committee Utrecht and Medical Research Ethics Committee AMC Amsterdam, approved an opt-out method of informed consent (protocol number 10–056 C, date: June 16, 2010) whereby participants and family members were notified of the study by a brochure with an attached opt-out card that was provided at ICU admission. The current analysis was additionally reviewed by the Medical Research Ethics Committee Utrecht (Medisch-Ethische Toetsingscommissie UMC Utrecht) and deemed exempt from the need for consent to participate in accordance with national regulations (protocol number 19–241 C, date April 3, 2019). For the current analysis, we obtained longitudinal data from consecutive subjects > 18 years who were admitted to the medical-surgical tertiary ICU of one of the participating centers (University Medical Center Utrecht in the Netherlands) between January 2011 and December 2018. All procedures were conducted in accordance with the Helsinki Declaration of 1975.
: Not applicable.
: Dr Varkila reported receiving grants from the ESICM Epimed Solutions Award on Quality Improvement and Patient Safety 2019 to support this work. Dr Bonten reported receiving grants through the Innovative Medicines Initiative Joint Undertaking through the COMBACTE-NET and COMBACTE-CARE projects, Johnson & Johnson, and Merck during the duration of this study, and personal fees from GSK and Shionogi for consulting outside the submitted work. Dr Cremer reported receiving grants from the ESICM Epimed Solutions Award on Quality Improvement and Patient Safety 2019 to support this work, and grants from ImmuneXpress Inc. (Seattle, WA), Abionic SA (Epalinges, Switzerland), Prolira BV (Utrecht, Netherlands) and Presymptom Health (Porton Down, UK) for biomarker studies related to sepsis diagnosis outside of this work. No other disclosures were reported.
: The peer review reports can be found at .
