COMPARISON OF EFFICACY OF INTRAVENOUS INFUSION VERSUS ORAL DILTIAZEM IN PATIENTS WITH ATRIAL FIBRILLATION AND RAPID VENTRICULAR RATE FOR RATE CONTROL:AN EXPLORATORY RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Achievement of rate control i.e ventricular rate 110/min at 4 hours after enrolment in the study.
研究概览
简要总结
Atrial fibrillation(AF) is the most common arrythmia encountered and treated by emergency physicians. Symptomatic relief and ventricular rate control are the primary therapeutic objectives in emergency management of acute AF, which can be achieved by either rate or rhythm control. We intend to conduct a study comparing the routes of administration of diltiazem - a calcium channel blocker in treating AF. This study will also asses occurance of adverse effects ,length of hospital/ emergency stay, need for other alternatives to achieve rate control as secondary outcomes. The study would be helpful in choosing the appropriate route of administration which determines the length of hospital stay, resource utilisation and level of monitoring required in emergency department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age >18yrs 2.Patients presenting to ED of AIIMS Rishikesh with Atrial Fibrillation (AF)with rapid ventricular rate (Ventricular rate >110/min) and having received initial diltiazem iv bolus (weight based).
排除标准
- •1.Hemodynamically unstable patients a)Systolic BP <90mmHg b)Acutely altered mental status c)Signs of shock d)Ischemic chest discomfort e)Acute heart failure 2.Any patient requiring electrical cardioversion.
- •3.Patients diagnosed with acute myocardial infarction.
- •4.Patients already received another antiarrhythmic agent within 24 hours before inclusion in study.
- •5.Patients in whom oral drug cannot be administered.
- •6.Hepatic dysfunction a)Decompensated chronic liver failure b)Severe acute hepatitis 7.Patients diagnosed with pre-excitation syndromes.
- •8.Patients not consenting to be part of the study.
结局指标
主要结局
1.Achievement of rate control i.e ventricular rate 110/min at 4 hours after enrolment in the study.
时间窗: 4 hour
次要结局
- 1.Need for additional intravenous (IV) boluses of diltiazem.(2.Need for switching from oral to iv infusion.)