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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.
Trials 2019; 20(1):420T

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.

Authors+Show Affiliations

Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.Statistics and Data Centre, Samsung Medical Centre, Seoul, South Korea.Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Centre, Seoul, South Korea.Department of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Centre, Seoul, South Korea.Department of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Centre, Seoul, South Korea.Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.Department of Emergency Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.Department of Emergency Medicine, Guro Hospital, Korea University Medical Centre, Seoul, South Korea.Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea. taegunshin@skku.edu.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

31296251

Citation

Hwang, Sung Yeon, et al. "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." Trials, vol. 20, no. 1, 2019, p. 420.
Hwang SY, Park JE, Jo IJ, et al. 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. Trials. 2019;20(1):420.
Hwang, S. Y., Park, J. E., Jo, I. J., Kim, S., Chung, S. P., Kong, T., ... Shin, T. G. (2019). 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. Trials, 20(1), p. 420. doi:10.1186/s13063-019-3542-x.
Hwang SY, et al. 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. Trials. 2019 Jul 11;20(1):420. PubMed PMID: 31296251.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hwang,Sung Yeon, AU - Park,Jong Eun, AU - Jo,Ik Joon, AU - Kim,Seonwoo, AU - Chung,Sung Phil, AU - Kong,Taeyoung, AU - Shin,Jonghwan, AU - Lee,Hui Jai, AU - You,Kyoung Min, AU - Jo,You Hwan, AU - Kim,Doyun, AU - Suh,Gil Joon, AU - Kim,Taegyun, AU - Kim,Won Young, AU - Kim,Youn-Jung, AU - Ryoo,Seung Mok, AU - Choi,Sung-Hyuk, AU - Shin,Tae Gun, AU - ,, Y1 - 2019/07/11/ PY - 2019/03/05/received PY - 2019/06/27/accepted PY - 2019/7/13/entrez PY - 2019/7/13/pubmed PY - 2020/1/15/medline KW - Resuscitation KW - Sepsis KW - Septic shock KW - Thiamine KW - Vitamin C SP - 420 EP - 420 JF - Trials JO - Trials VL - 20 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/31296251/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 L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3542-x DB - PRIME DP - Unbound Medicine ER -