MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Magnesium Sulfate 2g, Magnesium Sulfate 4g, Saline (0.9% NaCl).
- Кому может быть актуально
- Состояния в реестре: Atrial Flutter With Rapid Ventricular Response. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)
Обзор
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).
Подробное описание
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.
Вмешательства
- Препарат Magnesium Sulfate 2g
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) - Препарат Magnesium Sulfate 4g
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) - Препарат Saline (0.9% NaCl)
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
Первичные конечные точки
- Ventricular rate control [Срок оценки: Within the first 2 hours of intravenous magnesium administration]
Вторичные конечные точки (8)
- Mean change in heart rate [Срок оценки: up to 24 hours after magnesium infusion]
- Incidence of hypotension [Срок оценки: At 1 and 2 hours after magnesium administration]
- Incidence of bradycardia [Срок оценки: At 1 and 2 hours after magnesium administration]
- Mean time to achieve goal heart rate [Срок оценки: at 2 hours]
- Rate of conversion [Срок оценки: 2 hours after administration of magnesium]
- Clinical need for rescue medication administration [Срок оценки: 2 hours from metoprolol administration]
- Mean change in heart rhythm [Срок оценки: up to 24 hours after magnesium infusion]
- Clinical need for rescue medication administration [Срок оценки: 2 hours from metoprolol administration]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Advocate Christ Medical Center Emergency Department (ACMC ED) — Oak Lawn
Идентификаторы
NCT: NCT07632157 · IRB00146620