Publication:
Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support among Patients with Septic Shock: The VITAMINS Randomized Clinical Trial

Issued Date

2020-02-04

Resource Type

Conference Paper

ISSN

15383598
00987484

DOI

10.1001/jama.2019.22176

Other identifier(s)

2-s2.0-85077977882

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

JAMA - Journal of the American Medical Association. Vol.323, No.5 (2020), 423-431

Suggested Citation

Tomoko Fujii, Nora Luethi, Paul J. Young, Daniel R. Frei, Glenn M. Eastwood, Craig J. French, Adam M. Deane, Yahya Shehabi, Ludhmila A. Hajjar, Gisele Oliveira, Andrew A. Udy, Neil Orford, Samantha J. Edney, Anna L. Hunt, Harriet L. Judd, Laurent Bitker, Luca Cioccari, Thummaporn Naorungroj, Fumitaka Yanase, Samantha Bates, Forbes McGain, Elizabeth P. Hudson, Wisam Al-Bassam, Dhiraj Bhatia Dwivedi, Chloe Peppin, Phoebe McCracken, Judit Orosz, Michael Bailey, Rinaldo Bellomo Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support among Patients with Septic Shock: The VITAMINS Randomized Clinical Trial. JAMA - Journal of the American Medical Association. Vol.323, No.5 (2020), 423-431. doi:10.1001/jama.2019.22176 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/53761

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Title

Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support among Patients with Septic Shock: The VITAMINS Randomized Clinical Trial

Author(s)

Tomoko Fujii
 Nora Luethi
 Paul J. Young
 Daniel R. Frei
 Glenn M. Eastwood
 Craig J. French
 Adam M. Deane
 Yahya Shehabi
 Ludhmila A. Hajjar
 Gisele Oliveira
 Andrew A. Udy
 Neil Orford
 Samantha J. Edney
 Anna L. Hunt
 Harriet L. Judd
 Laurent Bitker
 Luca Cioccari
 Thummaporn Naorungroj
 Fumitaka Yanase
 Samantha Bates
 Forbes McGain
 Elizabeth P. Hudson
 Wisam Al-Bassam
 Dhiraj Bhatia Dwivedi
 Chloe Peppin
 Phoebe McCracken
 Judit Orosz
 Michael Bailey
 Rinaldo Bellomo

Other Contributor(s)

Graduate School of Medicine
 Melbourne Medical School
 Institut fur Sozial- und Praventivmedizin
 Western Health
 University of New South Wales (UNSW) Australia
 University of Melbourne
 Wellington Hospital, New Zealand
 Barwon Health
 Monash University
 Medical Research Institute of New Zealand
 Deakin University
 Faculty of Medicine, Siriraj Hospital, Mahidol University
 UniversitätsSpital Bern
 Hopital de la Croix-Rousse
 Alfred Hospital
 Austin Hospital
 Cancer Institute of the State of São Paulo

Abstract

© 2020 American Medical Association. All rights reserved. Importance: It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock. Objective: To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock. Design, Setting, and Participants: Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019. Interventions: Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days. Main Outcomes and Measures: The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality. Results: Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was-0.6 hours (95% CI,-8.3 to 7.2 hours; P =.83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported. Conclusions and Relevance: In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone.

Keyword(s)

Medicine

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URI

https://repository.li.mahidol.ac.th/handle/123456789/53761

Collections

Scopus 2020