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
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...
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| Format: | Article |
| Language: | English |
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BMC
2019-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3542-x |
| _version_ | 1818881236991475712 |
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| author | 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 for the Korean Shock Society (KoSS) Investigators |
| author_facet | 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 for the Korean Shock Society (KoSS) Investigators |
| author_sort | Sung Yeon Hwang |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-19T14:58:40Z |
| format | Article |
| id | doaj.art-8bf6451963be432a89a59a0415f5e8e2 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T14:58:40Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-8bf6451963be432a89a59a0415f5e8e22022-12-21T20:16:38ZengBMCTrials1745-62152019-07-012011810.1186/s13063-019-3542-xCombination therapy of vitamin C and thiamine for septic shock in a multicentre, double-blind, randomized, controlled study (ATESS): study protocol for a randomized controlled trialSung Yeon Hwang0Jong Eun Park1Ik Joon Jo2Seonwoo Kim3Sung Phil Chung4Taeyoung Kong5Jonghwan Shin6Hui Jai Lee7Kyoung Min You8You Hwan Jo9Doyun Kim10Gil Joon Suh11Taegyun Kim12Won Young Kim13Youn-Jung Kim14Seung Mok Ryoo15Sung-Hyuk Choi16Tae Gun Shin17for the Korean Shock Society (KoSS) InvestigatorsDepartment of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of MedicineDepartment of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of MedicineDepartment of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of MedicineStatistics and Data Centre, Samsung Medical CentreDepartment of Emergency Medicine, Yonsei University College of MedicineDepartment of Emergency Medicine, Yonsei University College of MedicineDepartment of Emergency Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical CentreDepartment of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical CentreDepartment of Emergency Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical CentreDepartment of Emergency Medicine, Seoul National University Bundang HospitalDepartment of Emergency Medicine, Seoul National University Bundang HospitalDepartment of Emergency Medicine, Seoul National University College of MedicineDepartment of Emergency Medicine, Seoul National University College of MedicineDepartment of Emergency Medicine, Asan Medical Centre, University of Ulsan College of MedicineDepartment of Emergency Medicine, Asan Medical Centre, University of Ulsan College of MedicineDepartment of Emergency Medicine, Asan Medical Centre, University of Ulsan College of MedicineDepartment of Emergency Medicine, Guro Hospital, Korea University Medical CentreDepartment of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of MedicineAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3542-xSepsisSeptic shockThiamineVitamin CResuscitation |
| spellingShingle | 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 for the Korean Shock Society (KoSS) Investigators 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 Sepsis Septic shock Thiamine Vitamin C Resuscitation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Sepsis Septic shock Thiamine Vitamin C Resuscitation |
| url | http://link.springer.com/article/10.1186/s13063-019-3542-x |
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