A Study to Evaluate the Efficacy of Intravenous Magnesium in the Management of Atrial Fibrillation with a Rapid Ventricular Rate in the Emergency Department

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: Following randomisation, there shall be two groups as detailed below. 1. Intervention Arm – Shall receive a single intravenous administration of 20mmol of Magnesium Sulfate in 100mls of normal 0.9% saline over 30 minutes. 2. Placebo Arm – Shall receive a single intravenous administration of 100mls of 0.9% normal saline over 30 minutes. The above interventions shall not be personalised, this is a randomised controlled study design trial and patients will all be required to sign a patient information and consent form detailing participant involvement, risks and study objectives. CONDITION: Atrial Fibrillation; ; Atrial Fibrillation Cardiovascular ‐ Other cardiovascular diseases PRIMARY OUTCOME: Primary Outcome ‐ Proportion of participants with a reduction of ventricular rate to <100 beats per minute or greater than 20% from initial heart rate at presentation. Note the primary timepoint shall be 1 hour post initiation of intervention/placebo. ; ; It is worth noting our secondary outcomes and their associated timepoints. ; ; Instrument to measure the primary outcome – Heart rate data shall be collected by the following;; ; (a) Departmental electrocardiogram every 30minutes for the first hour following commencement of the intervention then hourly thereafter (b) Telemetry (c) Routine nursing observations, at least hourly whilst in the Emergency Department ; ; ; [Primary Timepoint – 1 hours following initiation of intervention] SECONDARY OUTCOME: 1. Reversion on ECG/telemetry to sinus rhythm from atrial fibrillation ; ; [Data shall be recorded on heart rate and rhythm at 30, 60, 90, and 120 minutes, and 4 hour mark. ; In terms of this secondary outcome timepoint, thus there are multiple,] 2. Time elapsed from commencement of intervention to target (primary outcome) rate reduction[Assessed up to 4 hours post‐intervention (more specifically at 30, 60, 90, 120 and 240 minutes) by means of above methods (ECG serial, telemetry data retrospective analysis from stored date.] 3. Number of and dose of any further (besides magnesium sulfate, our intervention) of rate and/or rhythm control agents required to achieve target rate reduction. ; ; This shall be assessed by using the hospitals widely used EMR (Electronic Medical Record) and recorded on the confidential and anonymous RedCaps data collection software. [Assessed up to 4 hours post‐intervention and will include a review of medications used during initial admission period to gain rate or rhythm control. ] 4. Length of stay in the emergency department ; ; This shall be assessed by using the hospitals widely used EMR (Electronic Medical Record) and recorded on the confidential and anonymous RedCaps data collection software. ; [At hospital discharge, and through review of the electronic medical record for admission length. ] 5. Need for admission to hospital ward ; ; This shall be assessed by using the hospitals widely used EMR (Electronic Medical Record) and recorded on the confidential and anonymous RedCaps data collection software. ; [At hospital discharge, and through review of the electronic medical record to ascertain if there was an admission to any in‐patient ward. ] 6. Re‐hospitalisation at 30 days[30 days following intervention ; ; Assessed via electronic medical record EMR ] 7. Mortality at 30 days [Assessed via electronic medical record EMR ; ; Measured at 30 days following intervention] INCLUSION CRITERIA: 1. Greater than or equal to 18 years of age 2. ECG at presentation to Emergency Department greater than or equal to a ventricular rate of 120 3. Presenting complaint attributable to atrial fibrillation 4. Able to give informed consent
Epistemonikos ID: 54d1c876590ba809c970619a61861b2ff4a40333
First added on: Aug 24, 2024