Modulation of Endothelial Dysfonction Using Vitamin C in Septic Shock Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compare the change in microcirculatory vascular reactivity before and after a 30-minute intravenous infusion of 40 mg / kg vitamin C.
研究概览
简要总结
Compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C and evaluate intra-individual variation of hemodynamic parameters between T0 and T1.
详细描述
This is a transversal study allowing to compare the microcirculatory reactivity before and after a 30-minute intravenous infusion of 40 mg/kg vitamin C.
Design:
• A monocentric, open-label, transversal study
Sample size :
30 patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age > 18 years
- •Septic shock patient, reanimated and stabilized defined as:
- •Patients with sepsis (suspected infection + 2 SOFA points) according to the latest international and the need to receive norepinephrine to maintain an average blood pressure above 65 mmHg
- •Patient supported for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards and for less than 24 hours to limit confounding factors related to prolonged reanimation (sedation) and the empowerment of organ failures in general and vascular in particular. Hemodynamic stabilization will be defined as no increase in norepinephrine dosages
排除标准
- •Pregnant or nursing women,
- •Participation in another intervention research involving the human person or exclusion period following a previous research involving the human person
- •Ward or curative patient
- •Moribund patient
- •Estimated life expectancy less than 1 month
结局指标
主要结局
Compare the change in microcirculatory vascular reactivity before and after a 30-minute intravenous infusion of 40 mg / kg vitamin C.
时间窗: 30 minutes
Change (%) in microcirculatory vascular reactivity. T0 being measured just before the start of the vitamin C infusion. T1 being measured immediately after the 30-minute vitamin C infusion. The microcirculatory vascular reactivity will be evaluated using a cutaneous doppler laser coupled to an iontophoresis system. The doppler laser measures the skin perfusion on a sample of skin. A low intensity electric field is delivered for 12 seconds (3 times in a row at 1 minute interval) and allows local skin diffusion of an ionized solution of acetylcholine placed on the skin in a micro-sponge. It has been shown that this technique is very precise and that it is a very good reflection of endothelial function by measuring 3 parameters, the microcirculatory basal flow, the peak in response to acetylcholine and a more integrative index, the area under the curve with a standardized 10-minute recording. This local technique does not induce any side effects, it is very well tolerated.
次要结局
- To study the hemodynamic effects of vitamin C on cardiac output, hemodynamic parameters: HR, BP, clinical perfusion parameters: marbling score, cutaneous re-coloring time.(30 minutes)