Oral Bisoprolol Versus Intravenous Diltiazem in the Management of Atrial Fibrillation or Flutter with Rapid Ventricular Rate in the Emergency Department: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety Outcome Evaluated by the Presence of serious adverse event
研究概览
简要总结
INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.
METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.
AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.
PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR < 60 bpm and SBP < 95 mm Hg.
SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)
PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.
INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).
CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.
OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes.
详细描述
= Aim of the Study: This open-label randomized controlled trial (RCT) aims to assess the effectiveness and safety of oral bisoprolol in treating atrial fibrillation (AF) with rapid ventricular response (RVR) and atrial flutter within an acute ED setting. We aim to determine the viability of utilizing oral bisoprolol as a primary treatment option for atrial fibrillation with rapid ventricular response (RVR) and atrial flutter by evaluating its clinical outcomes, focusing on rate control and potential adverse effects, and comparing them with those of intravenous diltiazem. The findings from this research will enhance our understanding and guide clinicians towards evidence-based therapeutic decisions, ensuring optimal patient care and improved outcomes.
= Research Objectives and Hypothesis: The research aims to test the null hypothesis, which posits that there is no significant difference in achieving a heart rate (HR) below 110 beats/min or a reduction in ventricular rate by at least 20% between the oral bisoprolol (PO) and intravenous diltiazem (IV) groups after 60 minutes.
= Study Design: This is a prospective, open-label, randomized controlled trial that will be conducted as a single-center investigation within the Emergency Department of Sultan Qaboos University Hospital (SQUH). This study will involve adult patients aged 18 and older, and all eligible participants will be given written informed consent to join the research.
= Control Group: Participants in this group will be administered a single intravenous dose of diltiazem at a dosage of 0.25 mg/kg, with a maximum dose capped at 30 mg.
= Intervention Group: Participants in this group will receive a single oral dose of bisoprolol, set at a dosage of 5 mg, with a maximum dose limit of 5 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Investigator, Outcomes Assessor)
盲法说明
While the treating physician, nurse, and the patient will not be blinded to the treatment, the statistician analyzing it will remain blinded to treatment allocations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years old.
- •Atrial fibrillation (RVR) or Atrial flutter on electrocardiogram.
- •Heart rate >120 beats/min
- •Stable patient with stable vital signs (Defined as having a SBP >110 mmHg, oxygen saturation > 94% on room air or with a simple face mask, a respiratory rate within normal limits, being conscious and oriented, and not having any concurrent life-threatening conditions such as myocardial infarction (MI) or Class IV heart failure).
- •Mentally competent patient who can understand and sign the consent form.
排除标准
- •Acute myocardial infarction.
- •Known congenital and acquired valvular defects.
- •Pre-excitation syndromes.
- •Ventricular rate > 220beats/min.
- •Administration of AV nodal blocking agents within the previous 24 h (beta blockers, non-dihydropyridine calcium channel blockers, digoxin and amiodarone or receiving regular maintains oral dose).
- •Allergy to either bisoprolol or diltiazem.
- •Severe hepatic and renal failure.
- •Pregnancy / breastfeeding.
- •A history of cocaine or methamphetamine use within 24 hours before arrival.
- •Known Asthmatic.
研究组 & 干预措施
Oral Bisoprolol
A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg)
干预措施: Oral Bisoprolol (Drug)
Intravenous Diltiazem
single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg)
干预措施: Intravenous Diltiazem (Drug)
结局指标
主要结局
Safety Outcome Evaluated by the Presence of serious adverse event
时间窗: at 60 minutes
The primary safety outcome measures were HR \< 60 bpm and SBP \< 95 mm Hg
Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction
时间窗: at 60 minutes
The primary efficacy outcome evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes
次要结局
- ED revisit(First 48 hour from discharge)
- Proportion of patients who required hospitalization(90 minutes)
- The use of Rescue medication(60 minutes)
- Number of Participants Experiencing Treatment-Related Adverse Events(First 48 hour after receive intervention)
研究者
Fatin Khalfan Alomairi
Resident, Emergency Medicine, OMSB
Oman Medical Speciality Board