High-dose vitamin C on sepsis: Protocol of a prospective, multi-centered, double-blinded, randomized, and placebo-controlled superiority study

作者：Bing Zhao, Mengjiao Li, Wenwu Sun, Jian Li, Leshan Liu, Yihui Wang, Silei Sun, Lili Xu, Xingshun Qi, Mengqi Xie, Yuhua Zhou, Tongtian Ni, Yi Yao, Peili Chen, Meiling Yu, Weisong Jiang, Ning Ning, Huiqiu Sheng, Erzhen Chen, Ruilan Wang, Chaoyang Tong, Yu Cao, Mingwei Sun, Enqiang Mao · 发表于：Frontiers in Medicine · 年份：2022 · DOI：10.3389/fmed.2022.950246 · 被引用次数：2 · 研究领域：Vitamin C and Antioxidants Research、Antioxidant Activity and Oxidative Stress、Vitamin K Research Studies

Background: Sepsis is an inflammatory syndrome with life-threatening organ dysfunction and high mortality. In the recent 10 years, high-dose intravenous injection of vitamin C, the first-line antioxidant of humans, has received highlighted attention in the field of critical care. The study aims to examine the efficacy and safety of high-dose intravenous injection of vitamin C in the treatment of sepsis. Methods and design: Here, we are conducting a prospective, multi-centered, double-blinded, randomized, and placebo-controlled superiority study named High-Dose Vitamin C on Sepsis (HDVCOS). A total of 620 participants diagnosed with sepsis in four participating sites across China that satisfy the eligibility criteria will be randomized at a ratio of 1:1 to receive treatment with a high-dose intravenous injection of vitamin C (200 mg/kg/24 h) or placebo (saline) for 4 days. The primary outcome is 28 days of mortality. The secondary outcomes include the incidence of organ failure, Sequential Organ Failure Assessment (SOFA) score change, organ support, the relationship between plasma vitamin C concentration and outcomes, and adverse events. Conclusion: The findings of this study will provide potential evidence for high-dose intravenous injection of vitamin C in the treatment of sepsis. Clinical trial registration: [http://www.chictr.org.cn/showprojen.aspx?proj=29851], identifier [ChiCTR1800017633].