比较 2g 镁、4g 镁和安慰剂治疗 AFF RVR 的发生率 (ATRIUM)
静脉使用镁可减少房性心动过速 (ATRIUM) 研究：比较 2g 镁、4g 镁和安慰剂治疗 AFF RVR 的发生率
The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR.
研究概览
地位
详细说明
Intravenous magnesium has become a commonly utilized agent in the treatment of cardiac arrhythmias as an adjunct therapy to rate and rhythm control medications, such as its use in atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR). Though its benefit in the treatment of AFF RVR has been well documented, a consensus on the optimal dosing of magnesium has yet to be achieved. Only one randomized, controlled, double-blinded study has investigated the optimal dosing of magnesium.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Marc McDowell, PharmD
- 电话号码：(708) 684-1078
- 邮箱：marc.mcdowell@aah.org
学习地点
-
-
Illinois
-
Oak Lawn、Illinois、美国、60453
- 招聘中
- Advocate Christ Medical Center Emergency Department (ACMC ED)
-
接触：
- Marc McDowell, PharmD
- 电话号码：708-684-6230
- 邮箱：marc.mcdowell@aah.org
-
-
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:
- Age > 18 years or older
- Able to provide informed consent
- Primary diagnosis AFF RVR greater than or equal to 120 bpm
- Diltiazem as rate control agent
- English speaking
Exclusion Criteria:
- Hemodynamically unstable patients (SBP <90, MAP <65)
- Impaired consciousness
- End stage renal disease on hemodialysis or peritoneal dialysis
- Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and/or additional imaging
- Patient in AFF RVR that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis
- Rhythms other than AF, such as sick sinus syndrome or wide-complex ventricular response
- Acute myocardial infarction
- Pregnancy defined as a positive urine HCG (human chorionic gonadotropin)
- Contraindications to magnesium sulfate (including myasthenia gravis)
- Allergy or sensitivity to any study drugs
- Previously enrolled in this trial during a different patient encounter
- Withdrew from study
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental Arm One, Magnesium Sulfate 2g
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) |
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
其他名称：
|
|
实验性的：Experimental Arm Two, Magnesium Sulfate 4g
Magnesium Sulfate 4g/50ml 0.9% NaCl |
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
其他名称：
|
|
安慰剂比较：Control Arm, normal saline
50ml 0.9% NaCl |
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
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 |
|---|---|---|
|
Ventricular rate control
大体时间：Within the first 2 hours of intravenous magnesium administration
|
Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of < 120 bpm. |
Within the first 2 hours of intravenous magnesium administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to achieve goal HR (heart rate)
大体时间：2 hours
|
Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem |
2 hours
|
|
Rate of conversion
大体时间：2 hours after administration of magnesium
|
Rate of conversion to normal sinus rhythm (NSR) |
2 hours after administration of magnesium
|
|
Incidence of hypotension
大体时间：At 1 and 2 hours after magnesium administration
|
SBP < 90 mmHg or MAP (mean arterial pressure) < 65 |
At 1 and 2 hours after magnesium administration
|
|
Change in heart rate
大体时间：up to 24 hours after magnesium infusion
|
Mean change in heart rate up to 24 hours after magnesium infusion |
up to 24 hours after magnesium infusion
|
|
Clinical need for rescue medication administration
大体时间：2 hours from diltiazem administration
|
Dose and route of rescue medications given (magnesium and diltiazem) |
2 hours from diltiazem administration
|
|
Adverse effects
大体时间：2 hours from diltiazem administration
|
Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion) |
2 hours from diltiazem administration
|
合作者和调查者
调查人员
- 首席研究员：Travis Hase, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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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