Combination therapy of vitamin C and thiamine for septic shock: a multi-centre, double-blinded randomized, controlled st
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ORIGINAL
Combination therapy of vitamin C and thiamine for septic shock: a multi‑centre, double‑blinded randomized, controlled study Sung Yeon Hwang1, Seung Mok Ryoo2, Jong Eun Park1, You Hwan Jo3,4, Dong‑Hyun Jang3,4, Gil Joon Suh4, Taegyun Kim4, Youn‑Jung Kim2, Seonwoo Kim5, Hyun Cho5, Ik Joon Jo1, Sung Phil Chung6, Sung‑Hyuk Choi7, Tae Gun Shin1* , Won Young Kim2* and Korean Shock Society (KoSS) © 2020 Springer-Verlag GmbH Germany, part of Springer Nature
Abstract Purpose: To evaluate the effects of early combination therapy with intravenous vitamin C and thiamine on recovery from organ failure in patients with septic shock. Methods: The ascorbic acid and thiamine effect in septic shock (ATESS) trial was a multi-centre, double-blind, randomized, controlled trial conducted in four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020. Patients were randomly assigned in a 1:1 ratio to either the treatment group [intravenous vitamin C (50 mg/kg, maximum single dose 3 g) and thiamine (200 mg) administration every 12 h for a total of 48 h] or the placebo group (identical volume of 0.9% saline with the same protocol). The pri‑ mary outcome was Δ Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment–SOFA score after 72 h). Eighteen secondary outcomes were predefined, including shock reversal and 28-day mortality. Results: A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the placebo group. There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) − 1 to 5 vs. 3, IQR 0–4, respectively, p = 0.96]. Predefined second‑ ary outcomes were also not significantly different between the groups. Conclusion: In this study, vitamin C and thiamine administration in the early phase of septic shock did not improve organ function compared with placebo, despite improvements in vitamin C and thiamine levels. Keywords: Sepsis, Septic shock, Thiamine, Vitamin C, Resuscitation
*Correspondence: [email protected]; [email protected] 1 Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon‑ro, Gangnam‑gu, Seoul 06351, Korea 2 Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic‑ro 43‑gil, Songpa‑gu, Seoul 138‑736, Korea Full author information is available at the end of the article Sung Yeon Hwang, Seung Mok Ryoo, Tae Gun Shin and Won Young Kim contributed equally to this work.
Introduction Septic shock, a subset of sepsis, is characterized by severe circulatory and cellular metabolism abnormalities that are associated with a high risk of mortality [1]. Septic shock represents a major healthcare and socioeconomic burden worldwide. In a recent meta-analysis including studies from Europe and North America, mortality due to septic shock by the Sepsis-3 definition remains as high as 51.9% in the intensive care unit
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