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.

Christopher John LindsellAnna McGlothlinSamuel NwosuTodd W RiceAlex HallGordon R BernardLaurence W BusseE Wesley ElyAlpha A FowlerDavid F GaieskiJeremiah S HinsonMichael H HooperJames C JacksonGabor D KelenMark LevineGreg S MartinRichard E RothmanJonathan E SevranskyKert VieleDavid W WrightDavid N Hager

Published in: Trials (2019)

ClinicalTrials.gov, NCT03509350. Registered on 26 April 2018.

Keyphrases

double blind
placebo controlled
clinical trial
phase ii
phase iii
acute kidney injury
septic shock
randomized controlled trial
intensive care unit
study protocol
phase ii study
open label
radiation therapy
cross sectional