Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan Fujii, T, Udy, AA, Deane, AM, Luethi, N, Bailey, M, Eastwood, GM, Frei, D, French, C, Orford, Neil, Shehabi, Y, Young, PJ and Bellomo, R 2019, Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan, Critical Care and Resuscitation, vol. 21, no. 2, pp. 119-125. Attached Files Name Description MIMEType Size Downloads Title Vitamin C, Hydrocortisone and Thiamine in Patients with Septic Shock (VITAMINS) trial: study protocol and statistical analysis plan Author(s) Fujii, T Udy, AA Deane, AM Luethi, N Bailey, M Eastwood, GM Frei, D French, C Orford, Neil orcid.org/0000-0002-2285-9233 Shehabi, Y Young, PJ Bellomo, R Journal name Critical Care and Resuscitation Volume number 21 Issue number 2 Start page 119 End page 125 Total pages 7 Publisher College of Intensive Care Medicine of Australia and New Zealand Place of publication Melbourne, Vic. Publication date 2019-06 ISSN 1441-2772 Keyword(s) VITAMINS trial investigators Summary BACKGROUND: Septic shock is associated with poor outcomes. Vitamin C (ascorbic acid) is a cellular antioxidant and has anti-inflammatory properties. Whether the combination therapy of vitamin C, thiamine and hydrocortisone reduces vasopressor dependency in septic shock is unclear. OBJECTIVES: To describe the protocol and statistical analysis plan of a multicentre, open-label, prospective, phase 2 randomised clinical trial evaluating the effects of vitamin C, thiamine and hydrocortisone when compared with hydrocortisone monotherapy on the duration of vasopressor administration in critically ill patients with septic shock. METHODS: VITAMINS is a multicentre cardiovascular efficacy trial in adult patients with septic shock. Randomisation occurs via a secure website with stratification by site, and allocation concealment is maintained throughout the trial. The primary outcome is the duration of time alive and free of vasopressor administration at Day 7. Secondary outcomes include feasibility endpoints and some patientcentred outcomes. All analyses will be conducted on an intention-to-treat basis. CONCLUSION: The VITAMINS trial will determine whether combination therapy of vitamin C, thiamine and hydrocortisone when compared with hydrocortisone increases vasopressor-free hours in critically ill patients with septic shock. The conduct of this study will provide important information on the feasibility of studying this intervention in a phase 3 trial. TRIAL REGISTRATION: ClinicalTrials.gov, identification No. NCT03333278. Language eng Indigenous content off Field of Research 1103 Clinical Sciences 1110 Nursing HERDC Research category C1 Refereed article in a scholarly journal Free to Read? Yes Persistent URL http://hdl.handle.net/10536/DRO/DU:30155738 Document type: Journal Article Collections: Faculty of Health School of Medicine Related Links Link Description Connect to Elements publication management system Go to link with your DU access privileges     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Versions Version Filter Type Wed, 22 Sep 2021, 08:21:27 EST Wed, 22 Sep 2021, 08:41:03 EST Wed, 15 Dec 2021, 05:02:39 EST Wed, 02 Mar 2022, 08:37:45 EST Wed, 02 Mar 2022, 08:48:01 EST Wed, 02 Mar 2022, 08:52:03 EST Wed, 02 Mar 2022, 09:45:50 EST Thu, 03 Mar 2022, 08:38:52 EST Fri, 22 Apr 2022, 17:16:22 EST Fri, 22 Apr 2022, 17:17:00 EST Fri, 22 Apr 2022, 17:17:34 EST Filtered Full Citation counts:   Cited 17 times in TR Web of Science Cited 13 times in Scopus Search Google Scholar Access Statistics: 24 Abstract Views, 0 File Downloads  -  Detailed Statistics Created: Wed, 22 Sep 2021, 08:21:27 EST