Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Vasopressor dose
研究概览
简要总结
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.
Patients will be randomized to one of the study groups:
Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.
Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.
详细描述
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.
Patients will be randomized to one of the study groups:
Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.
Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.
Bottles will be identical, only identified by the sequential number of the patient that has been included.
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
- •Septic Shock
排除标准
- •Previous treatment exceeded 24 hours
- •Refusal to participate
- •Do Not Resuscitate
- •Participation in another trial
研究组 & 干预措施
Vitamin C
Vitamin C experimental group
干预措施: Vitamin C (Drug)
Control
Placebos Controlled group
干预措施: Placebos (Drug)
结局指标
主要结局
Vasopressor dose
时间窗: 72 hours
Hourly dose of exogenous vasopressor
次要结局
- Hours of vasopressor use(through study completion, an average of 30 days)
- Days of mechanical ventilation(through study completion, an average of 30 days)
- Days of Intensive Care Unit stay(through study completion, an average of 30 days)
- Mortality in Intensive Care Unit(through study completion, an average of 30 days)
研究者
Jose J Zaragoza, MD
Clinical Professor
Hospital Español de Mexico