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

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

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Article number420
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 2019 Jul 11

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Thiamine
Septic Shock
Ascorbic Acid
Randomized Controlled Trials
Acids
Therapeutics
Placebos
Organ Dysfunction Scores
Republic of Korea
Secondary Prevention
Multicenter Studies
Hospital Emergency Service
Control Groups
Survival
Research

Keywords

  • Resuscitation
  • Sepsis
  • Septic shock
  • Thiamine
  • Vitamin C

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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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. / 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.

In: Trials, Vol. 20, No. 1, 420, 11.07.2019.

Research output: Contribution to journalArticle

Hwang, SY, Park, JE, Jo, IJ, Kim, S, Chung, SP, Kong, T, Shin, J, Lee, HJ, You, KM, Jo, YH, Kim, D, Suh, GJ, Kim, T, Kim, WY, Kim, YJ, Ryoo, SM, Choi, SH & Shin, TG 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, vol. 20, no. 1, 420. https://doi.org/10.1186/s13063-019-3542-x
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. / 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. In: Trials. 2019 ; Vol. 20, No. 1.
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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.",
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T2 - 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

PY - 2019/7/11

Y1 - 2019/7/11

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.

AB - 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.

KW - Resuscitation

KW - Sepsis

KW - Septic shock

KW - Thiamine

KW - Vitamin C

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