维生素 B12 在感染性休克中的试验 (B12)
2026年5月26日 更新者：Jayshil J. Patel, MD、Medical College of Wisconsin
大剂量维生素 B12 在感染性休克中的 II 期双盲随机对照试验
这项研究将随机分配 20 名感染性休克患者，分别接受单次 5 克剂量的 IV 维生素 B12（Cyanokit® Meridian Medical Technologies，Columbia，MD）和安慰剂以及标准护理，以测试完成临床和实验室方案的可行性。
研究概览
详细说明
在获得患者合法授权代表的知情同意后，患者将被随机分配至羟钴胺或生理盐水。
患者将在服药前 3 小时和服药后 3 小时抽取血样，以测量硫化氢水平。
在输注研究药物后还将跟踪患者 3 小时，以监测和记录去甲肾上腺素等效剂量的血管加压药依赖性。
然后将通过他们的病历跟踪患者 28 天，以确定持续性器官功能障碍综合征 (PODS)。
研究类型
介入性
注册 (实际的)
20
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 至少 18 岁的成年患者
- 入住 Froedtert 医院的医疗重症监护室 (MICU) 服务
- 根据 sepsis-3 标准定义的感染性休克诊断
排除标准：
- 草酸钙史
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
实验性的：羟钴胺素
在 10-15 分钟内进行单次静脉输注
|
单次静脉注射维生素 B12
其他名称：
|
|
安慰剂比较：盐水安慰剂
在 10-15 分钟内给予单次 IV 生理盐水。
|
生理盐水单次静脉注射
其他名称：
|
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 |
|---|---|---|
|
Feasibility of Clinical and Protocol Completion
大体时间：28 days
|
Feasibility of completing clinical and laboratory protocols to the arm assigned
|
28 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
持续性器官功能障碍综合征 (PODS)
大体时间：28天
|
持续性器官功能障碍综合征 (PODS) 的患病率
|
28天
|
|
Hydrogen Sulfide Concentration
大体时间：30 minutes post infusion
|
Difference between pre- and post-dose hydrogen sulfide levels
|
30 minutes post infusion
|
|
Change in Vasopressor Dose
大体时间：3 hours
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Vasopressor dose in mcg/kg/min (norepinephrine equivalents)
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3 hours
|
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ICU Mortality
大体时间：during ICU stay, up to 30 days
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Intensive care unit mortality
|
during ICU stay, up to 30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jayshil J Patel, MD、Medical College of Wisconsin
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年8月5日
初级完成 (实际的)
2023年2月23日
研究完成 (实际的)
2023年2月23日
研究注册日期
首次提交
2018年12月19日
首先提交符合 QC 标准的
2018年12月19日
首次发布 (实际的)
2018年12月20日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月26日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.