Midodrine Hydrochloride in Early Sepsis
2021年2月4日 更新者：Ognjen Gajic、Mayo Clinic
Oral Midodrine Hydrochloride in Early Sepsis: Randomized, Double Blind and Placebo-Controlled Feasibility Study
The investigators would like to determine if early administration of oral Midodrine in participants diagnosed with sepsis will impact blood pressures and decrease the need for and/or doses of intravenous pressor agents.
研究概览
详细说明
Three doses of either placebo or midodrine every 8 hours will be administered in addition to usual care for sepsis.
The goal will be to administer the first dose approximately within 24 hours of diagnosis.
The first dose will be administered only after the patient has been admitted to the ICU.
Subjects will receive treatment for a total of 16 hours starting from the first dose.
The medical provider, nursing staff and patient will be blinded to randomization, only research pharmacist will be aware of randomization.
Blood pressure will be recorded at least on a 4 hourly basis for 24 hours from the time of administration of the first dose, and also just prior to administration of each dose.
Subsequent doses will be held if systolic blood pressure, SBP, is greater than 130 mmHg.
If a subject requires initiation of intravenous vasopressor agents following study enrollment, subsequent doses will be continued.
There will be no further intervention after all 3 doses have been administered; however clinical outcomes and adverse events will be monitored.
研究类型
介入性
注册 (实际的)
33
阶段
- 阶段1
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
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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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
有资格学习的性别
全部
描述
Inclusion Criteria:
Patients diagnosed with sepsis based on the old Sepsis criteria and meeting all of the following criteria will be considered eligible to participate in the study.
- Age greater than or equal to 18 years
- Able to safely tolerate medication either by mouth or feeding tube (i.e. absence of nausea or vomiting)
- Able to give consent for participation or have representative available
- Two or more blood pressure readings taken at least 15 minutes apart with mean arterial pressures, MAPs 70 or less
- Treating consultant agrees to the study plan
Exclusion Criteria:
Patients meeting any one of the following criteria will be excluded from participation:
- Women of child bearing age with the potential to become pregnant who do not have a clinically documented negative pregnancy test
- Current cardiogenic shock or known systolic heart failure with left ventricular ejection fraction (LVEF) < 30%
- Current bowel ischemia
- Recent Myocardial infarction within the past 3 months
- Current use of Monoamine Oxidase Inhibitors (MAOIs)
- Recent Stroke within the past 3 months
- Midodrine as a home medication
- Known allergy to Midodrine
- High dose vasopressor use (norepinephrine >0.25 mcg/kg/min)
- Lactate more than 8 mmol/L
- Contraindications to use: History of pheochromocytoma or thyrotoxicosis or glaucoma or ischemic bowel disease
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 |
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有源比较器：Midodrine Hydrochloride 10 milligrams
Three doses of oral midodrine every 8 hours will be administered in addition to usual care for sepsis.
Participants randomized to the intervention group will receive a total of 3 doses of midodrine 10 milligrams every 8 hours by mouth in the form of a tablet encapsulated in order to be identical to placebo.
Participants will receive treatment for a total of 16 hours, beginning with the first dose.
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Three doses taken every 8 hours.
其他名称：
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安慰剂比较：Placebo oral capsule
For participants randomized to the placebo arm, an identical appearing capsule containing only Lactose Monohydrate powder will be administered every 8 hours for a total of 3 doses.
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Three doses taken every 8 hours.
其他名称：
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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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Duration of Vasopressor Use
大体时间：24 hours
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To study the duration of vasopressor use in the first 24 hours of sepsis
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean arterial blood pressure (MAP)
大体时间：24 hours after the first drug dose
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Routinely measured mean arterial blood pressure, invasive and noninvasive
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24 hours after the first drug dose
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Cumulative Fluid Balance
大体时间：24 hours after sepsis onset
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To study the cumulative fluid balance during the first 24 hours of sepsis
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24 hours after sepsis onset
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ICU and hospital length of stay, central venous access use and organ failure
大体时间：The first 7 days of study enrollment or until discharge
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Daily Simplified Organ Failure Assessment, SOFA, scores
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The first 7 days of study enrollment or until discharge
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Incidence of potential side effects attributable to Midodrine
大体时间：48 hours after enrollment
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To study the potential side effects attributable to Midodrine use in diagnosis of Sepsis.
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48 hours after enrollment
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Cumulative Vasopressor Dose
大体时间：24 hours after the first drug dose
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To study the cumulative vasopressor dose requirements during the first 24 hours after study drug initiation
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24 hours after the first drug dose
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2017年8月30日
初级完成 (实际的)
2020年4月28日
研究完成 (实际的)
2020年5月15日
研究注册日期
首次提交
2017年4月6日
首先提交符合 QC 标准的
2017年4月23日
首次发布 (实际的)
2017年4月26日
研究记录更新
最后更新发布 (实际的)
2021年2月5日
上次提交的符合 QC 标准的更新
2021年2月4日
最后验证
2021年2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.
Midodrine Hydrochloride 10 milligrams的临床试验
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