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NCT06376916PHASE3Recruiting

Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR

Wake Forest University Health Sciences

Start Date

10/7/2024

Completion Date

12/1/2026

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Magnesium Sulfate 2 G

DRUG

Magnesium Sulfate 4 G

DRUG

Saline

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Conditions

Tachycardia AtrialAtrial FibrillationAtrial Flutter With Rapid Ventricular Response

Locations

Advocate Christ Medical Center Emergency Department (ACMC ED)

Oak Lawn, Illinois 60453

United States