• Sung Yeon Hwang, Jong Eun Park, Ik Joon Jo, Seonwoo Kim, Sung Phil Chung, Taeyoung Kong, Jonghwan Shin, Hui Jai Lee, Kyoung Min You, You Hwan Jo, Doyun Kim, Gil Joon Suh, Taegyun Kim, Won Young Kim, Youn-Jung Kim, Seung Mok Ryoo, Sung-Hyuk Choi, Tae Gun Shin, and Korean Shock Society (KoSS) Investigators.
• Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.
• Trials. 2019 Jul 11; 20 (1): 420.

BackgroundSeptic 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.MethodsThis 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).DiscussionThis 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 RegistrationClinicalTrials.gov, NCT03756220 . Registered on 5 December 2018.

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