MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 196
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to find out if the use of magnesium in addition to Metoprolol, a rate controlling medication that you would be offered in the Emergency Department today unrelated to this study, will help reduce your high heart rate (rapid ventricular response).
详细描述
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. 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 atrial fibrillation or atrial flutter with rapid ventricular response. This study will use flat-dose intravenous metoprolol for rate control to minimize confounders. Additionally, this study will not require a resulted magnesium level prior to treatment in order to avoid delays in patient care.
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
- Double (Participant, Investigator)
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
- •Age > 18 years or older
- •Able to provide informed consent
- •Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute
- •Metoprolol as rate control agent
- •English speaking
排除标准
- •Hemodynamically unstable patients (SBP <90, MAP <65)
- •Impaired consciousness
- •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 atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response
- •Acute myocardial infarction
- •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
研究组 & 干预措施
Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol
Study drug (Magnesium Sulfate 4 gram/50ml 0.9% NaCl) will be administered over a time interval of 15 minutes. Immediately after study drug administration, intravenous metoprolol 5 mg will be administered as an IV push over 2 minutes. Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of study drug will not be administered. Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
干预措施: Magnesium Sulfate 4g (Drug)
Control Arm, normal saline followed by metoprolol
50ml 0.9% NaCl will be administered over a time interval of 15 minutes. Intravenous metoprolol 5 mg will be immediately administered as an IV push over 2 minutes. Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of saline will not be administered. Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
干预措施: Saline (0.9% NaCl) (Drug)
Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) will be administered over a time interval of 15 minutes. Immediately after study drug administration, intravenous metoprolol 5 mg will be administered as an IV push over 2 minutes. Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of study drug will not be administered. Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
干预措施: Magnesium Sulfate 2g (Drug)