Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Ventricular rate control
研究概览
简要总结
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.
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.
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 AFF RVR greater than or equal to 120 bpm
- •Diltiazem as rate control agent
- •English speaking
排除标准
- •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
研究组 & 干预措施
Experimental Arm One, Magnesium Sulfate 2g
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)
干预措施: Magnesium Sulfate 2 G (Drug)
Experimental Arm Two, Magnesium Sulfate 4g
Magnesium Sulfate 4g/50ml 0.9% NaCl
干预措施: Magnesium Sulfate 4 G (Drug)
Control Arm, normal saline
50ml 0.9% NaCl
干预措施: Saline (Drug)
结局指标
主要结局
Ventricular rate control
时间窗: 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.
次要结局
- Rate of conversion(2 hours after administration of magnesium)
- Incidence of hypotension(At 1 and 2 hours after magnesium administration)
- Change in heart rate(up to 24 hours after magnesium infusion)
- Clinical need for rescue medication administration(2 hours from diltiazem administration)
- Time to achieve goal HR (heart rate)(2 hours)
- Adverse effects(2 hours from diltiazem administration)