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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg | Experimental | 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. |
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| Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol | Experimental | 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. |
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| Control Arm, normal saline followed by metoprolol | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate 2g | Drug | Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) |
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| Measure | Description | Time Frame |
|---|---|---|
| Ventricular rate control | Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of < 120 beats per minute. | Within the first 2 hours of intravenous magnesium administration |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in heart rate | Mean change in heart rate after the administration of magnesium sulfate | up to 24 hours after magnesium infusion |
| Incidence of hypotension | Systolic blood pressure < 90 or MAP < 65 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc McDowell, PharmD | Contact | (708) 684-1078 | marc.mcdowell@aah.org | |
| Thomas Szwajnos | Contact | Thomas.Szwajnos@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Marc McDowell, PharmD | Advocate Christ Medical Center Emergency Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center Emergency Department (ACMC ED) | Oak Lawn | Illinois | 60453 | United States |
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Magnesium Sulfate 4g | Drug | Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) |
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| Saline (0.9% NaCl) | Drug | The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes. |
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| At 1 and 2 hours after magnesium administration |
| Incidence of bradycardia | Heart rate < 60 beats per minute | At 1 and 2 hours after magnesium administration |
| Mean time to achieve goal heart rate | Mean time to achieve goal heart rate at 2 hours | at 2 hours |
| Rate of conversion | Rate of conversion to normal sinus rhythm | 2 hours after administration of magnesium |
| Clinical need for rescue medication administration | Dose of rescue medications given (magnesium and metoprolol) | 2 hours from metoprolol administration |
| Mean change in heart rhythm | Mean change in heart rhythm after the administration of magnesium sulfate | up to 24 hours after magnesium infusion |
| Clinical need for rescue medication administration | Route of administration (IV or PO) for rescue medications (magnesium and metoprolol), if administered. | 2 hours from metoprolol administration |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |