Frank, Hannah E.
Evans, Laura
Phillips, Gary
Dellinger, RPhillip
Goldstein, Jessyca
Harmon, Lori
Portelli, David
Sarani, Nima
Schorr, Christa
Terry, Kathleen M.
Townsend, Sean R.
Levy, Mitchell M. http://orcid.org/0000-0001-8556-2405
Funding for this research was provided by:
NHLBI Division of Intramural Research (1RO1HL162954-01)
Article History
Received: 22 June 2023
Accepted: 12 September 2023
First Online: 29 September 2023
Declarations
:
: All sites recruited for this trial will be instructed to follow their hospital’s research policies for local IRB approval. In addition and as is required by the National Institutes of Health, a central IRB (wcg IRB) has been established for full study review with each site submitting for central approval (Protection of Human Subjects #35170744.0; Protocol Version 2.0). The study and protocol (including the Data Safety Monitoring Plan and DSMB charter) was approved by the IRB at Rhode Island Hospital (CMTT/PROJ #218420). Any changes to study procedures or the study protocol will be reviewed by the central IRB. The central IRB approved a waiver of consent for patients enrolled in this study given that both interventions are now considered as the standard of care in alignment with the Centers for Medicare and Medicaid Services SEP-1 core measures. Because of the challenge to define “unanticipated events” for sepsis, the investigators have been advised of the following: “If any investigator observes what they believe to be a significant adverse event that is definitely or possibly related to the study procedure, please report this to the Project Manager (Lori Harmon) and the Principal Investigator (Mitchell Levy) within 24 h of the event.”
: Not applicable.
: Dr. Evans is co-chair Adult Surviving Sepsis Guidelines, co-author of SSC 1-h bundle, and member of Scientific Advisory Board for Endpoint Health (USA). Dr. Dellinger has held a leadership position Surviving Sepsis Campaign 2002–2016. Dr. Schorr has been in a leadership position for the Surviving Sepsis Campaign from 2006 to present, and is a paid consultant on the current grant (R01HL162954). Dr. Townsend is a measure steward for the Centers for Medicare and Medicaid Services sepsis quality measure. Dr. Levy receives funding from T32 HL134625, 1RO1HL162954-0, is co-author of the SSC 1-h bundle, and is on scientific advisory boards for Inotrem (France) and Endpoint Health (USA). All other authors declare that they have no competing interests.