Treating Vitamin C Deficiency in Septic Shock: Would it Help?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- C-reactive protein
研究概览
简要总结
Objectives: investigators aim to study the effect of addition of vitamin C as a part of treatment in septic shock patients on: Hemodynamics, Inflammation status and ICU outcome.
Subjects and methods: A prospective interventional randomized cohort study, was conducted on 150 consecutive patients who were admitted to the ICU with septic shock based on SIRS, SOFA and APACHE II. Treatment group (n=75) had given ascorbic acid (Vitamin C) parenterally 6gm daily and control group (n=75). Measuring the level of Vitamin C in all study population (normal range 50-70 μM/L) before and after period of 4 days.
详细描述
AIM OF THE WORK investigators aim to study the effect of addition of vitamin C in septic shock patients on:
- Mean arterial pressure
- C-reactive protein as an inflammatory marker
- Vasopressors ( norepinephrine) dose and duration.
- ICU outcome ( ICU stay, 7 and 28 days mortality)
SUBJECTS AND METHODS
Study type A prospective interventional randomized cohort study carried out at Critical Care Department, Cairo University Hospitals with 25 ICU beds for medical and surgical patients, in the period between December 2021 to January 2023.
An informed consent from 1st degree relatives was taken and confidentiality of information was assured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Septic shock (defined by sepsis induced hypotension i.e. MAP < 65 mmHg, tissue hypo-perfusion, vasopressors
排除标准
- •Age below 18 years old
研究组 & 干预措施
Vitamin C group
Ascorbic acid (Vitamin C) was given parenterally (2 gm every 8hrs) for 4 days.
干预措施: Ascorbic acid (Drug)
Control group
No vit C given
干预措施: Ascorbic acid (Drug)
结局指标
主要结局
C-reactive protein
时间窗: Evaluated on a daily basis for 4 days
C-reactive protein level III- Vasopressor (noradrenaline) dose and duration
Mean arterial blood pressure
时间窗: Evaluated on a daily basis for 4 days
Mean arterial blood pressure (MAP).
次要结局
- ICU Length of stay . II- 7 day mortality rate. III- 28 days mortality(28 days)
- ICU mortality(28 days)
研究者
Mostafa Farouk
Lecturer of critical care
Cairo University