The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis
The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis. Randomized Double-Blind Placebo-Controlled Trial
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kaunas、立陶宛
- Lithuanian University of Health Sciences Hospital Kaunas Clinics
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with sepsis or septic shock within the first 24 hours after ICU admission.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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. |
200mg/kg/24h in four equal parts
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安慰剂比较：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.
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The same regimen as ascorbic acid.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Microvascular flow index (MFI)
大体时间：Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Changes in MFI
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Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Proportion of perfused small vessels (PPV)
大体时间：Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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Changes in PPV
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Baseline, after 0.5, 6, 12, 24, 48, 72 and 96 hours
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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