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临床试验/NCT06262932
NCT06262932已完成4 期

Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response

Police General Hospital, Thailand1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Heart rate

研究概览

简要总结

The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

  • Repeated dosing regimen
  • Standard dosing regimen

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years old
  • Atrial fibrillation with rapid ventricular response patient (ventricular rate > 110)

排除标准

  • Baseline EKG Corrected QT interval (QTc) < 500 msec
  • History of pulmonary fibrosis
  • History of Cirrhosis
  • Cardiac Index <2.2 L/min/m2 or Cardiogenic shock
  • Unstable arrhythmia
  • Receive amiodarone within 3 months prior to present illness
  • Pregnancy
  • Amiodarone or Iodine allergy

研究组 & 干预措施

Repeated amiodarone bolus dosing regimen

Active Comparator

An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period. If the heart rate is still over 110 minutes after the initial treatment, provide an additional 150 mg IV amiodarone bolus over a 15-minute period. During the first 24 hours, this bolus may be administered up to three times in total. Within 24 hours of finishing the first bolus dosage, 900 mg of amiodarone will be administered intravenously.

干预措施: Amiodarone (Drug)

Standard dosing regimen

Active Comparator

An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period, then a 24-hour amiodarone loading infusion 900 mg over 24 hours

干预措施: Amiodarone (Drug)

结局指标

主要结局

Heart rate

时间窗: 6-hours after receiving amiodarone bolus

Percentage of patients who have Atrial fibrillation with rapid ventricular response, the percentage of patients who have heart rate below 110 bpms at 6 hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have heart rate below 110 bpms at 6 hour after a conventional amiodarone IV loading dose regimen

次要结局

  • Heart rate(24-hours after receiving amiodarone bolus)
  • Major adverse cardiovascular events(30 days after receiving amiodarone bolus)
  • Phlebitis(24-hours after receiving amiodarone bolus)
  • Normal sinus rhythm at 24 hours(24-hours after receiving amiodarone bolus)
  • Changed in heart rate(24-hours after receiving amiodarone bolus)

研究者

发起方
Police General Hospital, Thailand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chawit Lopimpisuth

Principal Investigator

Police General Hospital, Thailand

研究点 (1)

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