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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tachycardia Atrial Atrial Fibrillation Atrial Flutter With Rapid Ventricular Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Arm One, Magnesium Sulfate 2g

Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)

Group Type EXPERIMENTAL

Magnesium Sulfate 2 G

Intervention Type DRUG

Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)

Experimental Arm Two, Magnesium Sulfate 4g

Magnesium Sulfate 4g/50ml 0.9% NaCl

Group Type EXPERIMENTAL

Magnesium Sulfate 4 G

Intervention Type DRUG

Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)

Control Arm, normal saline

50ml 0.9% NaCl

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Interventions

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Magnesium Sulfate 2 G

Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)

Intervention Type DRUG

Magnesium Sulfate 4 G

Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)

Intervention Type DRUG

Saline

The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Intervention Type DRUG

Other Intervention Names

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Magnesium Sulfate 2 gram/50ml 0.9% NaCl Magnesium Sulfate 4g/50ml 0.9% NaCl Control (50ml 0.9% NaCl)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No