BACKGROUND Sepsis is a health problem of global importance; treatments focus on controlling infection and supporting failing organs. Recent clinical research suggests that intravenous vitamin C may decrease mortality in sepsis. We have designed a randomized controlled trial (RCT) to ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days in patients with sepsis. METHODS LOVIT (Lessening Organ dysfunction with VITamin C) is a multicenter, parallel-group, blinded (participants, clinicians, study personnel, Steering Committee members, data analysts), superiority RCT (minimum n = 800). Eligible patients have sepsis as the diagnosis for admission to the intensive care unit (ICU) and are receiving vasopressors. Those admitted to the ICU for more than 24 h are excluded. Eligible patients are randomized to high-dose intravenous vitamin C (50 mg/kg every 6 h for 96 h) or placebo. The primary outcome is a composite of death or persistent organ dysfunction (need for vasopressors, invasive mechanical ventilation, or new and persisting renal replacement therapy) at day 28. Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia). Six subgroup analyses are planned. DISCUSSION This RCT will provide evidence of the effect of high-dose intravenous vitamin C on patient-important outcomes in patients with sepsis. TRIAL REGISTRATION clinicaltrials.gov, NCT03680274, first posted 21 September 2018.

中文翻译：

---

VITamin C（LOVIT）减轻器官功能障碍：一项随机对照试验的方案。

背景技术败血症是具有全球重要性的健康问题。治疗的重点是控制感染和支持衰竭的器官。最近的临床研究表明，静脉注射维生素C可以降低败血症的死亡率。我们设计了一项随机对照试验（RCT），以确定败血症患者在第28天服用维生素C对死亡或持续器官功能障碍的复合终点的影响。方法爱心（使用VITamin C导致的器官功能障碍）是多中心，平行组，双盲的（参与者，临床医生，研究人员，指导委员会成员，数据分析员），RCT优势（最低n = 800）。符合条件的患者患有败血症，可作为重症监护病房（ICU）的诊断，并正在接受升压药治疗。那些进入ICU超过24小时的患者被排除在外。符合条件的患者被随机分配至大剂量静脉注射维生素C（每6小时50 mg / kg，持续96 h）或安慰剂。主要结局是在第28天死亡或持续器官功能障碍（需要使用升压药，有创机械通气或进行新的和持续的肾脏替代疗法）的复合结果。次要结局包括至第28天无持续器官功能障碍，死亡率和健康状况- 6个月时的相关生活质量，乏力，炎症，感染，内皮功能和不良反应（溶血，急性肾损伤和低血糖）的生物标志物。计划进行六个亚组分析。讨论该RCT将为大剂量静脉注射维生素C对败血症患者重要的预后产生影响提供证据。试验注册临床试验.gov，NCT03680274，首次发布于2018年9月21日。