2022-500717-64-00招募中2 期
Efficacy of early intravenous high-dose vitamin C in post-cardiac arrest shock: a multicenter, randomized controled to standard treatment, open label trial.
Centre Hospitalier Bethune Beuvry, Centre Hospitalier Bethune Beuvry, Centre Hospitalier Bethune Beuvry14 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2023年3月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 14
- 主要终点
- Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
研究概览
简要总结
Our main objective is to assess the efficacy of IV high-dose vit-C to reduce the need for vasopressor within the first 3 days in patients who suffered from an OHCA with a post-CA shock.
研究设计
- 分配方式
- Randomized
- 主要目的
- Study design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •patients still comatose (Glasgow coma scale < 8)
- •an OHCA of presumed cardiac origin with ROSC < 60 min
- •treated with a norepinephrin or an epinephrin continuous infusion ≥ 0.2µg/kg/h, within 4 hours after OHCA, during at least 30 min/h to maintain mean arterial pressure (MAP) ≥ 65 mmHg.
排除标准
- •pre-existent severe chronic kidney disease (glomerular filtration rate < 30ml/min)
- •moribound or chronic disease (life expectancy <1 an).
- •Patient with legal protective measures
- •Patient not covered by French national health insurance
- •known vit-C deficit
- •Patient with derpived freedom
- •Hyperoxaluria
- •Hystory of urolithiasis
- •pregnant women
- •OHCA from evident extracardiac cause (trauma, bleeding, poisoning, etc..)
- •interval between OHCA and randomization > 4 hours
- •extracorporeal circulatory assistance requirement in the first 4 hours after OHCA
- •Hypersensitivity of active substance or méthyl parahydroxybenzoate or dipropyl
- •Contraindication to vitamine C (glucose-6-phosphate deshydrogenase deficiency; hemochromatosis)
- •patients already treated with vit-C;
- •inclusion in another interventional study in cardiac arrest or post CA
结局指标
主要结局
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
Cumulative incidence of weaning from vasopressors at day 3 after OHCA.
次要结局
- Cumulative incidence of death by refractory shock within 7 days after OHCA.
- the neurological outcome at day 28 after OHCA, assessed using the mRS (favorable neurological outcome will be considered if mRS range from 0 to 3; Unfavorable neurological outcome will be considered if mRS range from 4 to 6).
- The maximal vasopressors infusion dose within 3 days after OHCA.
- The delta SOFA (sepsis-related organ failure assessment score) is defined as the difference between SOFA admission and SOFA at 72 hours after OHCA. Death within 72 hours will be counted as the maximum SOFA score (i.e. 24 points).
- The lower arterial lactate level at day 3 after OHCA.
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Bethune Beuvry
研究点 (14)
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