VItamin C in Thermal injuRY: The VICToRY Trial A Phase III Multi-center Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 666
- 试验地点
- 49
- 主要终点
- Persistent Organ Dysfunction + Death
研究概览
简要总结
This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.
详细描述
In certain disease states, such as those associated with severe burns and other critical illnesses, the relationship between nutrient deficiencies, altered immune status, and acquired infection has been recognized for many years. More than in any other injury, the inflammation and catabolism associated with severe burns can exacerbate nutrient deficiencies, thereby predisposing patients to impaired immune function and increased risk of developing infectious complications, organ dysfunction, and death.
We aim to conduct a large-scale, multi-center randomized trial to evaluate the effect of high-dose (50mg/kg every 6 hours for 96 hours) intravenous vitamin C in addition to standard of care (SOC) on 28-days composite outcome of Persistent Organ Dysfunction (POD) and all-cause mortality compared to add-on placebo and SOC.
Patients will be allocated to 2 groups, active or control: patients in the active group will receive intravenous vitamin C at 50mg/kg every 6 hrs for 96 hrs. Patients in the control group will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C. This study will be the first large international multi-centre trial examining the effects of high dose intravenous vitamin C in burn patients. It represents a unique collaboration of burn units worldwide that is coordinated by the Clinical Evaluation Research Unit, based in Kingston Ontario Canada, a coordinating center that has demonstrated the ability to run multi-center trials and translate findings into practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation will be random and concealed and will be blinded to everyone except the pharmacist at each site. The vitamin C will be sourced locally and prepared in a blinded manner by local research pharmacies that will be responsible for preparing study samples and delivering them to the ICU in a blinded fashion. The randomization system, which has proven reliable in several prior RCTs, has a robust audit trail, and will maintain concealment and blinding.
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
- •18 years of age or older
- •Deep 2nd and/or 3rd degree burns requiring skin grafting
- •Minimum burn size of ≥ 20% Total Body Surface Area (TBSA)
排除标准
- •>24 hours from admission to participating hospital to consent.
- •Patients admitted to burn unit >24 from injury or accident.
- •Patients who are moribund (not expected to survive the next 72 hours).
- •Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
- •Enrollment in another industry sponsored ICU intervention study.
- •Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
- •Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •Recent history of kidney stones (within the last year).
- •Concomitant use of hydroxycobalamin (vitamin B12) for suspected cyanide poisoning.
研究组 & 干预措施
Control group
Patients will receive a similar amount of placebo (either D5W or saline) delivered in the same manner as the vitamin C.
干预措施: placebo (Drug)
Vitamin C
Patients will receive intravenous vitamin C at 50mg/kg every 6 hours for 96 hours
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Persistent Organ Dysfunction + Death
时间窗: at 28 days
Persistent organ dysfunction (PODS)+death, a novel composite endpoint that combines being alive and being free of organ support (inotropes or vasopressors, renal replacement therapy and mechanical ventilation)
Time to discharge alive from hospital
时间窗: 90 days
Time to discharge alive from hospital, a composite of mortality and length of stay is similar to "ventilator- free days", which is a widely accepted and commonly used outcome in intensive care research.
次要结局
- Time to discharge alive from hospital(90 days)
- Components of PODS+28-day mortality(28 days)
- POD (persistent organ dysfunction)-free days(28 days)
研究者
Daren K. Heyland
Dr. Daren Heyland, MD, MSc, FRCPC
Clinical Evaluation Research Unit at Kingston General Hospital