The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Microvascular flow index (MFI)
研究概览
简要总结
The purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.
详细描述
Adult patients with septic shock were enrolled within 24 hours following admission to the Central Department of Intensive Care in Lithuanian University of Health Sciences Hospital Kaunas Clinics.
Participants were randomly assigned to a placebo or ascorbic acid group in a 1:1 ratio. They were resuscitated according to Surviving Sepsis Campaign Guidelines. Additionally, they received an intravenous infusion of ascorbic acid either placebo. The dose of ascorbic acid was 200mg/kg/24h divided into four equal parts for 96 hours. Sublingual microcirculatory measurements were obtained, using an incident dark field (IDF) device.
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
- •Patients with sepsis or septic shock within the first 24 hours after ICU admission.
排除标准
- •Age < 18 years,
- •Pregnancy,
- •Advanced malignancy,
- •History of kidney stone, glucose-6-phosphate deficiency, hemochromatosis, or solid organ transplantation,
- •Oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
研究组 & 干预措施
Placebo
Patients received placebo solution matching ascorbic acid solution as four equal parts daily for 96 hours. Images of sublingual microcirculation were obtained at a baseline, after 0.5, 6, 12, 24, 48, 72, and 96 hours.
干预措施: Placebo (Drug)
Ascorbic acid
Patients received a high dose of intravenous ascorbic acid in four equal parts daily for 96 hours.
Images of sublingual microcirculation were obtained at a baseline, after 0.5, 6, 12, 24, 48, 72, and 96 hours.
干预措施: Ascorbic acid (Drug)
结局指标
主要结局
Microvascular flow index (MFI)
时间窗: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Changes in MFI
Proportion of perfused small vessels (PPV)
时间窗: Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
Changes in PPV
次要结局
未报告次要终点
研究者
Andrius Pranskunas
Professor
Lithuanian University of Health Sciences