Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Admission Rate
研究概览
简要总结
The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart rate >125
- •Systolic BP>110
- •Atrial Fibrillation/Flutter confirmed on ECG.
- •Meets observation unit requirements (performs certain ADL's (acts of daily living)
排除标准
- •Wolf-Parkinson-White syndrome
- •ST Elevation Myocardial Infarction
- •Clinical diagnosis of Sepsis,
- •Decompensated HF
- •allergy to Diltiazem
- •provider discretion
- •clinical need for cardioversion
研究组 & 干预措施
Diltiazem with oral and intravenous treatment
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP<100
干预措施: Oral (Drug)
traditional atrial fibrillation with rapid ventricular response
these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and they must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.
干预措施: Intravenous drug (Drug)
结局指标
主要结局
Admission Rate
时间窗: 1 days
This will compare rates of patients admitted between the protocol group and patients treated traditionally
Treatment Success at 3 Hours
时间窗: 3 hours
This will compare the total number of patients who in 3 hours from first medicine administration achieved heart rate less than 110 between the protocol and traditional treatment group
次要结局
- Rate of Hypotension(1 day)