Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments: a Multicentre, Double Blinded, Randomized Controlled Trial: the C-EASIE Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 8
- 主要终点
- Sequential Organ Failure Assessment (SOFA) score
研究概览
简要总结
In this clinical trial the effect of early administration of Vitamin C is investigated in patients admitted at the emergency department with sepsis or septic shock.
When a patient has sepsis, his/her body is causing damage to its own tissues and organs as result of an infection. This can lead to septic shock. The patient has a low blood pressure, his/her organs stop working and the patient may even die.
The aim of this trial is to investigate the efficiency of Vitamin C in sepsis and septic shock. Vitamin C is a vitamin present in various foods and has been approved as dietary supplement by the Belgian authorities. Over the years it has been proven that Vitamin C is very safe. In addition, several studies have shown that Vitamin C can also have a protective effect. It can reduce organ damage and increase survival rates. Although several studies suggest that Vitamin C can help fight sepsis, it is not yet used in practice. This Belgian trial, in which several hospitals participate, hopes to provide a clear answer to the question: "Should Vitamin C be administered to patients admitted in an emergency department with sepsis or 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
- •Patient has a 'suspected infection': this requires the combination of antibiotic administration and body fluid cultures within the first 6 hours after Emergency Department presentation.
- •Patient has a NEWS score ≥ 5.
排除标准
- •Patient (≥18 years old) or legally authorized representative didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available.
- •antibiotic administration as a single dose or as a prophylactic treatment.
- •antibiotics administered without an accompanying body fluid culture according to the timeframe (within 6 hours after emergency department presentation).
- •'Do no intubate' or 'comfort measures only' status.
- •Failure to randomize within 6 hours after Emergency Department presentation.
- •Weight < 45 kg.
- •Pregnant or breastfeeding.
- •Known allergy for Vitamin C.
- •Known history of oxalate nephropathy or hyperoxaluria.
- •Known history of glucose-6-phosphate dehydrogenase deficiency.
- •Known history of chronic iron overload due to iron storage and other diseases.
- •The patient is already on IV steroids for a reason other than septic shock.
- •Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID-19 within 14 days prior to or at ED presentation).
- •Participation in an interventional trial with an investigational medicinal product (IMP) or device
研究组 & 干预措施
standard care + placebo
The 'standard care' group will receive intermittent infusion of normal saline (3 ampoules of 5 ml 9mg/ml normal saline diluted in 50 ml of normal saline, every 6 hours) during 4 days or until hospital discharge and is started within 6 hours after presentation (time of triage) in the ED.
干预措施: Normal saline (Drug)
standard care + Vitamin C
The 'standard care + Vitamin C' group will receive intermittent infusion of Vitamin C (3 ampoules of 500 mg/5ml Vitamin C diluted in 50 ml of normal saline, every 6 hours) during 4 days or until hospital discharge and is started within 6 hours after presentation (time of triage) in the ED.
干预措施: Vitamin C (Drug)
结局指标
主要结局
Sequential Organ Failure Assessment (SOFA) score
时间窗: 5 days
Average post-baseline patient SOFA score, SOFA score range: 0-24, with 24 being the worst outcome (death)
次要结局
- need for Renal Replacement Therapy (RRT)(5 days)
- duration of Renal Replacement Therapy (RRT)(5 days)
- 28-day mortality(28 days)
- Maximum SOFA score(5 days)
- Length of hospital stay(3 months)
- Dosage Vasopressors(5 days)
- Ventilator days(3 months)
- Time to return to work(3 months)
- Length of ICU stay(3 months)
- Duration Vasopressors(5 days)
- Steroids(5 days)
- Quality of life questionnaire (EQ-5D-5L)(3 months)