In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol
Christopher J Lindsell, Anna McGlothlin, Samuel Nwosu, Todd W Rice, Alex Hall, Gordon R Bernard, Laurence W Busse, E Wesley Ely, Alpha A Fowler, David F Gaieski, Jeremiah S Hinson, Michael H Hooper, James C Jackson, Gabor D Kelen, Mark Levine, Greg S Martin, Richard E Rothman, Jonathan E Sevransky, Kert Viele, David W Wright, David N Hager, Christopher J Lindsell, Anna McGlothlin, Samuel Nwosu, Todd W Rice, Alex Hall, Gordon R Bernard, Laurence W Busse, E Wesley Ely, Alpha A Fowler, David F Gaieski, Jeremiah S Hinson, Michael H Hooper, James C Jackson, Gabor D Kelen, Mark Levine, Greg S Martin, Richard E Rothman, Jonathan E Sevransky, Kert Viele, David W Wright, David N Hager
Abstract
ClinicalTrials.gov: NCT03509350. Registered on 26 April 2018.
Conflict of interest statement
CJL reports funding for the VICTAS trial to his institution from the Marcus Foundation, grants, and contracts to his institution from the National Institutes of Health and Endpoint Health and is named as co-inventor on patents related to risk stratification in septic shock. AM and KV are salaried employees of Berry Consultants, which is under contract with Emory University to support the design work and execution of the VICTAS trial. AH reports funding for the VICTAS trial to his institution from the Marcus Foundation as well as grants from the National Institutes of Health (NIH), Cerenovus, Sense Diagnostics, and the NICO Corporation. SN, GRB, DNH, JSH, REM, TR, and RER report funding for the VICTAS trial to their institutions from the Marcus Foundation. 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, etc.). ML is supported by the Intramural Research Program, NIDDK, NIH. DK053212–12: Ascorbic acid as a pharmacologic agent in disease treatment. GSM reports grants for the VICTAS Trial to his institution from the Marcus Foundation as well as grants from National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA) and Bristol-Myers Squibb to his institution. 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 Critical Care Medicine. 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.
References
- Hager DN, Hooper MH, Bernard GR, Busse LW, Ely EW, Fowler AA, et al. The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial. Trials. 2019;20(1):197. doi: 10.1186/s13063-019-3254-2.
- Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589–1596. doi: 10.1097/01.CCM.0000217961.75225.E9.
- Marik PE, Payen D. CITRIS-ALI: How statistics were used to obfuscate the true findings. Anaesth Crit Care Pa. 2019;38(6):575–577. doi: 10.1016/j.accpm.2019.10.004.
- Brant EB, Angus DC. Is high-dose vitamin C beneficial for patients with sepsis? JAMA. 2019;322(13):1257–1258. doi: 10.1001/jama.2019.11643.
Source: PubMed