Atrial Flutter With Rapid Ventricular Response
Conditions
Keywords
AFF RVR, intravenous magnesium, atrial flutter
Brief summary
The purpose of this research study is to find out if the use of magnesium in addition to Metoprolol, a rate controlling medication that you would be offered in the Emergency Department today unrelated to this study, will help reduce your high heart rate (rapid ventricular response).
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. 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 atrial fibrillation or atrial flutter with rapid ventricular response. This study will use flat-dose intravenous metoprolol for rate control to minimize confounders. Additionally, this study will not require a resulted magnesium level prior to treatment in order to avoid delays in patient care.
Interventions
DRUGMagnesium Sulfate 2g
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
DRUGMagnesium Sulfate 4g
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
DRUGSaline (0.9% NaCl)
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years or older * Able to provide informed consent * Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute * Metoprolol as rate control agent * English speaking
Exclusion criteria
* Hemodynamically unstable patients (SBP \<90, MAP \<65) * Impaired consciousness * 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 atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response * Acute myocardial infarction * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 beats per minute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in heart rhythm | up to 24 hours after magnesium infusion | Mean change in heart rhythm after the administration of magnesium sulfate |
| Incidence of hypotension | At 1 and 2 hours after magnesium administration | Systolic blood pressure \< 90 or MAP \< 65 |
| Incidence of bradycardia | At 1 and 2 hours after magnesium administration | Heart rate \< 60 beats per minute |
| Mean time to achieve goal heart rate | at 2 hours | Mean time to achieve goal heart rate at 2 hours |
| Rate of conversion | 2 hours after administration of magnesium | Rate of conversion to normal sinus rhythm |
| Clinical need for rescue medication administration | 2 hours from metoprolol administration | Dose of rescue medications given (magnesium and metoprolol) |
| Mean change in heart rate | up to 24 hours after magnesium infusion | Mean change in heart rate after the administration of magnesium sulfate |
Countries
United States
Contacts
CONTACTMarc McDowell, PharmD
CONTACTThomas Szwajnos
PRINCIPAL_INVESTIGATORMarc McDowell, PharmD
Advocate Christ Medical Center Emergency Department
Outcome results
None listed