Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial

Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial

Abstract Background Observational research suggests that combined therapy with Vitamin C, thiamine and hydrocortisone may reduce mortality in patients with septic shock. Methods and design The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a multicenter, double-blind, adaptive sample s...

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Main Authors: 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
Format: Article
Language:English
Published: BMC 2019-12-01
Series:Trials
Subjects:
Statistical analysis plan
Adaptive sample size
Vitamin C
Thiamine
Steroids
Sepsis
Online Access:https://doi.org/10.1186/s13063-019-3775-8

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