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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm One, Magnesium Sulfate 2g | Experimental | Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) |
|
| Experimental Arm Two, Magnesium Sulfate 4g | Experimental | Magnesium Sulfate 4g/50ml 0.9% NaCl |
|
| Control Arm, normal saline | Placebo Comparator | 50ml 0.9% NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate 2 G | Drug | Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) |
|
| 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 bpm. | Within the first 2 hours of intravenous magnesium administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve goal HR (heart rate) | 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 |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| Travis Hase, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center Emergency Department (ACMC ED) | Recruiting | Oak Lawn | Illinois | 60453 | United States |
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| Magnesium Sulfate 4 G | Drug | Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) |
|
|
| Saline | Drug | The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes. |
|
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Rate of conversion to normal sinus rhythm (NSR)
| 2 hours after administration of magnesium |
| Incidence of hypotension | SBP < 90 mmHg or MAP (mean arterial pressure) < 65 | At 1 and 2 hours after magnesium administration |
| Change in heart rate | 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 | Dose and route of rescue medications given (magnesium and diltiazem) | 2 hours from diltiazem administration |
| Adverse effects | Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion) | 2 hours from diltiazem administration |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
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