Clinical Efficacy of Megadose Vitamin C in Sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 5
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
In this multicenter, randomized, single-blind, placebo-controlled clinical trial. Patients will be randomly assigned to receive Vitamin C or placebo for 4 days or until ICU discharge (whatever come first). The primary outcome is 28-day all-cause mortality.
详细描述
Investigational drug: Vitamin C for injection
Study title: Clinical efficacy of megadose vitamin C in sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University
Study subjects: Adult septic/septic shock patients with procalcitonin(PCT)≥2ng/ml at recruitment.
Study phase: Investigator Initiated Trial(IIT)
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for sepsis-3 developed by the American Society of Critical Care Medicine (SCCM)/European Critical Care Medicine Association (ESICM)
- •Age ≥18 years old and age ≤80 years old.
- •Procalcitonin ≥2 ng/ml
排除标准
- •Age<18 years, or age>80 years.
- •Pregnancy or lactating
- •A solid-organ or bone marrow transplant patients.
- •Patients with myocardial infarction within the past 3 months.
- •Advanced pulmonary fibrosis .
- •Patients with cardiopulmonary resuscitation before enrollment.
- •HIV-positive patients.
- •granulocyte-deficient patients.
- •blood/lymphatic system tumors are not remission.
- •patients with limited care (lack of commitment to full aggressive life support).
- •patients with long-term use of immunosuppressive drugs or with immunodeficiency.
- •patients with advanced tumors.
- •patients combined with non-infectious factors leading to the death(uncontrollable major bleeding, brain hernia, etc.).
- •surgically unresolved infection sources(such as some intraperitoneal infection etc.)
- •patients allergic to vitamin c.
- •patients with G6PD deficiency.
研究组 & 干预措施
Placebo group
5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge.
干预措施: 5% glucose injection (Drug)
Megadose vitamin C group
12 g vitamin C (48 ml) will intravenously injected by a infusion pump every 12 h for 4 days or until ICU discharge
干预措施: Vitamin C (Drug)
结局指标
主要结局
28-day all-cause mortality
时间窗: The outcome will be assessed at the 28 day after enrollment
All-cause mortality from the enrollment to the 28th days
次要结局
- liver function(3)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- kidney function(2)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- inflammatory response(2)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- liver function(1)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- liver function(2)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- inflammatory response(1)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- Sequential Organ Failure Assessment (SOFA) score(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- The cessation of vasoactive drugs administration(The outcome will be assessed at the 28 day after enrollment)
- ICU length of stay(The outcome will be assessed at the 28 day after enrollment)
- Indicators of infection(2)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- The cessation of mechanical ventilation(MV) administration(The outcome will be assessed at the 28 day after enrollment)
- lung function(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- kidney function(3)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- Indicators of infection(1)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- kidney function(1)(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
- The duration of CRRT(The outcome will be assessed at the 28 day after enrollment)
- The level of lactate(The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment)
研究者
Liu Zhanguo
Vice director of the department of critical care medicine, Principal Investigator
Zhujiang Hospital