Advocate Christ Medical Center Emergency Department (ACMC ED)
Oak Lawn, Illinois, 60453, United States
Location status: Recruiting
NCT Number: NCT06376916
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Oak Lawn, Illinois, 60453, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Other names: Magnesium Sulfate 2 gram/50ml 0.9% NaCl
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Other names: Magnesium Sulfate 4g/50ml 0.9% NaCl
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
Other names: Control (50ml 0.9% NaCl)
Time frame: 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.
Time frame: 2 hours
Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem
Time frame: 2 hours after administration of magnesium
Rate of conversion to normal sinus rhythm (NSR)
Time frame: At 1 and 2 hours after magnesium administration
SBP < 90 mmHg or MAP (mean arterial pressure) < 65
Time frame: up to 24 hours after magnesium infusion
Mean change in heart rate up to 24 hours after magnesium infusion
Time frame: 2 hours from diltiazem administration
Dose and route of rescue medications given (magnesium and diltiazem)
Time frame: 2 hours from diltiazem administration
Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
Acronym: ATRIUM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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