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Article History

Received: 10 December 2018

Accepted: 27 February 2019

First Online: 5 April 2019

Ethics approval and consent to participate

: The study protocol and consent form have been approved by a cIRB at Johns Hopkins University (IRB protocol number: IRB00164053). Prior to the activation of any participating site, the protocol approved by the cIRB will be reviewed by each site’s local IRB to ensure compliance with local standards and regulations. Similarly, the cIRB approved consent form will be reviewed locally by the IRB of each participating site and amended so that it is compliant with local standards and regulations. Potential participants or legally authorized representatives (if applicable) at each site will be approached by credentialed study personnel at each site to inform them of the study. Participants or legally authorized representatives (if applicable) will provide consent.

: Not applicable.

: EWE reports funding for the VICTAS trial to his institution from the Marcus Foundation and has received honoraria from Pfizer, Orion, and Masimo for continuing medical education activities (no speakers’ bureaus or stocks and so on). DNH, GRB, AH, JSH, JCJ, REM, and RER report funding for the VICTAS trial to his institution from the Marcus Foundation. CJL was named as co-inventor on patents related to risk stratification in septic shock. AM and KV are salaried employees of Berry Consulting, which is under contract with Emory University to support the design work and execution of the VICTAS trial. DWW reports the grant for the VICTAS trial to his institution from the Marcus Foundation as well as grants from the National Institutes of Health (NIH), the National Highway Transportation Safety Administration, the Department of Defense, NICO Corporation, and the Centers for Disease Control and Prevention. JES reports grants for the VICTAS trial to his institution from the Marcus Foundation, funding from the Biomedical Advanced Research and Development Authority, and a stipend from the Society of Critical Care Medicine to support his editorial position for the journal <i>Critical Care Medicine</i>. GSM reports grants for the VICTAS trial to his institution from the Marcus Foundation as well as grants from the NIH and Bristol-Myers Squibb to his institution. MHH, LWB, ABF, DFG, GDK and ML declare that they have no competing interests.<b>Access to data:</b> A de-identified dataset from participants in the VICTAS trial will be made publicly available about one year after publication of the primary manuscript.<b>Dissemination and authorship policy:</b> The VICTAS trial publications protocol (Additional file) will ensure the rapid and accurate translation of study results to the scientific, medical, and global community and maximize the scholarly productivity of the trial. The protocol will outline the steps needed for publishing data related to the VICTAS trial, including concept generation and submission, writing and analysis responsibilities, and authorship.

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