Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- 90-day mortality
研究概览
简要总结
The purpose of this study is to determine whether the combination therapy (vitamin C,thiamine and hydrocortisone) is effective in the treatment of septic shock.
详细描述
Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.
A potential benefit of vitamin C with thiamine and low-dose hydrocortisone in the treatment of septic shock has recently been described(PMID 27940189) . The patients with septic shock who received this combination of medications weaned off pressors earlier, suffered less organ failure, and had improved mortality. The doses of vitamin C used in this trial are high, yet seemed to be safe and can be considered for use.
In this randomized controlled trial, we aim to evaluate the effect of the combination therapy (vitamin C,thiamine and hydrocortisone) on septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or older
- •Onset of septic shock within 12 hours
排除标准
- •Systemic corticosteroid therapy within the last 3 months before septic shock
- •High-dose steroid therapy
- •Immunosuppression
- •Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
- •Known hemachromatosis
- •Known allergy to vitamin C, hydrocortisone, or thiamine
- •Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician)
- •Refusal of the attending staff or patient family
研究组 & 干预措施
Vitamin C,thiamine,hydrocortisone
The combination of vitamin C, thiamine, hydrocortisone :
Vitamin C 2g every 6 hours x 5-days Thiamine 200mg every 12 hours x 5-days Hydrocortisone 200mg as a continuous infusion x 5-days
干预措施: Vitamin C,thiamine,hydrocortisone (Drug)
Placebo
Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components
干预措施: Placebo (Drug)
结局指标
主要结局
90-day mortality
时间窗: 90 days after randomization
Death from any cause at 90 days after the onset of septic shock
次要结局
- 28-day mortality(28 days after randomization)
- Hospital mortality(90 days after randomization)
- ICU mortality(90 days after randomization)
研究者
Qing-quan Lv
Principal Investigator
Northern Jiangsu People's Hospital