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Combination therapy of vitamin C and thiamine for septic shock in a multicentre, double-blind, randomized, controlled study (ATESS): study protocol for a randomized controlled trial

Cited 8 time in Web of Science Cited 5 time in Scopus
Authors
Hwang, Sung Yeon; Park, Jong Eun; Jo, Ik Joon; Kim, Seonwoo; Chung, Sung Phil; Kong, Taeyoung; Shin, Jonghwan; Lee, Hui Jai; You, Kyoung Min; Jo, You Hwan; Kim, Doyun; Suh, Gil Joon; Kim, Taegyun; Kim, Won Young; Kim, Youn-Jung; Ryoo, Seung Mok; Choi, Sung-Hyuk; Shin, Tae Gun
Issue Date
2019-07-11
Publisher
BioMed Central
Citation
Trials. 20(1):420
Keywords
SepsisSeptic shockThiamineVitamin CResuscitation
Abstract
Background
Septic shock is a life-threatening condition with underlying circulatory and cellular/metabolic abnormalities. Vitamin C and thiamine are potential candidates for adjunctive therapy; they are expected to improve outcomes based on recent experimental and clinical research. The aim of the Ascorbic Acid and Thiamine Effect in Septic Shock (ATESS) trial is 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
This study is a randomized, double-blind, placebo-controlled, multicentre trial in adult patients with septic shock recruited from six emergency departments in South Korea. Patients will be randomly allocated into the treatment or control group (1:1 ratio), and we will recruit 116 septic shock patients (58 per group). For the treatment group, vitamin C (50 mg/kg) and thiamine (200 mg) will be mixed in 50 ml of 0.9% saline and administered intravenously every 12 h for a total of 48 h. For the placebo group, an identical volume of 0.9% saline will be administered in the same manner. The primary outcome is the delta Sequential Organ Failure Assessment (SOFA) score (ΔSOFA = initial SOFA at enrolment – follow-up SOFA after 72 h).

Discussion
This trial will provide valuable evidence about the effectiveness of vitamin C and thiamine therapy for septic shock. If effective, this therapy might improve survival and become one of the main therapeutic adjuncts for patients with septic shock.

Trial registration
ClinicalTrials.gov, NCT03756220. Registered on 5 December 2018.
ISSN
1745-6215
Language
English
URI
http://hdl.handle.net/10371/160393
DOI
https://doi.org/10.1186/s13063-019-3542-x
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College of Medicine/School of Medicine (의과대학/대학원)Emergency Medicine (응급의학전공)Journal Papers (저널논문_응급의학전공)
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