Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
- Conditions
- Tachycardia AtrialAtrial FibrillationAtrial Flutter With Rapid Ventricular Response
- Interventions
- Drug: SalineDrug: Magnesium Sulfate 2 GDrug: Magnesium Sulfate 4 G
- Registration Number
- NCT06376916
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 153
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm, normal saline Saline 50ml 0.9% NaCl Experimental Arm One, Magnesium Sulfate 2g Magnesium Sulfate 2 G Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) Experimental Arm Two, Magnesium Sulfate 4g Magnesium Sulfate 4 G Magnesium Sulfate 4g/50ml 0.9% NaCl
- Primary Outcome Measures
Name Time Method Ventricular rate control 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.
- Secondary Outcome Measures
Name Time Method Rate of conversion 2 hours after administration of magnesium Rate of conversion to normal sinus rhythm (NSR)
Incidence of hypotension At 1 and 2 hours after magnesium administration SBP \< 90 mmHg or MAP (mean arterial pressure) \< 65
Change in heart rate up to 24 hours after magnesium infusion Mean change in heart rate up to 24 hours after magnesium infusion
Clinical need for rescue medication administration 2 hours from diltiazem administration Dose and route of rescue medications given (magnesium and diltiazem)
Time to achieve goal HR (heart rate) 2 hours Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem
Adverse effects 2 hours from diltiazem administration Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)
Trial Locations
- Locations (1)
Advocate Christ Medical Center Emergency Department (ACMC ED)
🇺🇸Oak Lawn, Illinois, United States