AFF RVRの治療率におけるマグネシウム2g、4g、プラセボの比較 (ATRIUM)
マグネシウムの静脈内使用による心房頻脈の減少（ATRIUM）研究：AFF RVRの治療率におけるマグネシウム2g、4g、プラセボの比較
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Marc McDowell, PharmD
- 電話番号：(708) 684-1078
- メール：marc.mcdowell@aah.org
研究場所
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Illinois
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Oak Lawn、Illinois、アメリカ、60453
- 募集
- Advocate Christ Medical Center Emergency Department (ACMC ED)
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コンタクト：
- Marc McDowell, PharmD
- 電話番号：708-684-6230
- メール：marc.mcdowell@aah.org
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental Arm One, Magnesium Sulfate 2g
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) |
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
他の名前：
|
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実験的：Experimental Arm Two, Magnesium Sulfate 4g
Magnesium Sulfate 4g/50ml 0.9% NaCl |
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
他の名前：
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プラセボコンパレーター：Control Arm, normal saline
50ml 0.9% NaCl |
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ventricular rate control
時間枠：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. |
Within the first 2 hours of intravenous magnesium administration
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to achieve goal HR (heart rate)
時間枠：2 hours
|
Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem |
2 hours
|
|
Rate of conversion
時間枠：2 hours after administration of magnesium
|
Rate of conversion to normal sinus rhythm (NSR) |
2 hours after administration of magnesium
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Incidence of hypotension
時間枠：At 1 and 2 hours after magnesium administration
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SBP < 90 mmHg or MAP (mean arterial pressure) < 65 |
At 1 and 2 hours after magnesium administration
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|
Change in heart rate
時間枠：up to 24 hours after magnesium infusion
|
Mean change in heart rate up to 24 hours after magnesium infusion |
up to 24 hours after magnesium infusion
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Clinical need for rescue medication administration
時間枠：2 hours from diltiazem administration
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Dose and route of rescue medications given (magnesium and diltiazem) |
2 hours from diltiazem administration
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Adverse effects
時間枠：2 hours from diltiazem administration
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Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion) |
2 hours from diltiazem administration
|
協力者と研究者
捜査官
- 主任研究者：Travis Hase, MD、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。